BEUDAMED
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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014

    AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·September 25, 2019

    PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG A/R LONG PHA01252 PROFEMUR NECK 8DG VAR/VAL SHORT PHA01254 PROFEMUR NECK 8DG VAR/VAL LONG PHA01256 PROFEMUR NECK 8DG VAR/VAL X LONG PHA01262 PROFEMUR NECK 15DG VAR/VAL SHORT PHA01264 PROFEMUR NECK 15DG VAR/VAL LONG Intended Use: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

    FDA Enforcement
    Class II ·Ongoing·MicroPort Orthopedics Inc.·September 16, 2020

    ADJUSTABLE DRILL GUIDE, BLACK MAX

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    7.2cm Adjustable Drill Guide Product Usage: Electric system

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·May 10, 2017

    Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

    FDA Enforcement
    Class II ·Terminated·Flower Orthopedics Corporation·October 13, 2021

    Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK - Sterile water is used in making dilutions of samples/transport media in preparation for microbial testing of the sample. It is also used for diluting sterile reagents and microorganism preparations

    FDA Enforcement
    Class II ·Ongoing·Edge Biologicals Inc·April 30, 2025

    AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The drill sleeve guides are accessories to the Ad-Tech Cranial Drill Bits. The Cranial Drill Bits and accessories are intended to be used for drilling holes in the skull for neurological procedures, such as brain biopsy, brain contacting electrode and electrode accessory device placement. The DSG-6.3-090-2.4N drill sleeve guides are intended to be used with the 2.4mm Cranial Drill Bit diameter.

    FDA Enforcement
    Class II ·Terminated·Ad-Tech Medical Instrument Corporation·August 1, 2018

    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr

    FDA Enforcement
    Class II ·Terminated·Pdg Product Design Group Inc·October 1, 2014

    BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

    FDA Enforcement
    Class II ·Terminated·Surgical Specialties Mexico S DE RL DE CV·October 19, 2016

    Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL "PROCOTYL(R) E" SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL "PROCOTYL(R) E" SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL "PROCOTYL(R) E" SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL "PROCOTYL(R) E" SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL "PROCOTYL(R) E" SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL "PROCOTYL(R) E" SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL "PROCOTYL(R) E" SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION "PROFEMUR(R) Z" SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION "PROFEMUR(R) Z" SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION "PROFEMUR(R) Z" SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION "PROFEMUR(R) Z" SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION "PROFEMUR(R) Z" SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION "PROFEMUR(R) Z" SIZE 8, PHA00616, Lot Numbers: X01238304, X01399402, X03393771, X03400458, X04393780, and X04400459 STEM REVISION "PROFEMUR(R) Z" SIZE 9, PHA00618, Lot Numbers: X01238305, X03393772, X03399404, and X04393781 STEM REVISION "PROFEMUR(R) Z" SIZE 10, PHA00620, Lot Numbers: X02399405, X03393773, and X04393782 STEM REVISION "PROFEMUR(R) Z" SIZE 11, PHA00622, Lot Numbers: X02377571, X03393774, and X04393783 CROCHET POUR COTYLE "PROCOTYL(R) E" L=18 (VERSION 3, PHA01106, Lot Numbers: V0181677, X03391269, and X03396706 CROCHET POUR COTYLE "PROCOTYL(R) E" L=23 (VERSION 3, PHA01107, Lot Numbers: U0366131, V0271861, W11376812, and X03391270 ILIAC PLATE "L" SHAPE "PROCOTYL(R) E" LEFT, PHA01110, Lot Number: X05420073 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" LEFT, PHA01120, Lot Number: X03396709 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" RIGHT, PHA01122, Lot Numbers: W07327875, X03391271, and X06401587 ILIAC PLATE DOUBLE "PROCOTYL(R) E" LEFT 4 HOLES, PHA01134, Lot Number: X03396707 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 4 HOLES, PHA01144, Lot Number: X03396708 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 5 HOLES, PHA01145, Lot Number: X03396359 PROFEMUR(R) NECK NEUTRALSHORT SHORT, PHA01202, Lot Numbers: U0781477, V02143965, V05185849, and X06420151 PROFEMUR(R) NECK NEUTRAL LONG, PHA01204, Lot Numbers: U0671647 and X03396401 PROFEMUR(R) NECK A/R VAR/VAL 2 SHORT, PHA01212, Lot Numbers: U0681198, U1185239, W12383174, X01388472, X02396405, X04401230, and X05418352 PROFEMUR(R) NECK A/R VAR/VAL 2 LONG, PHA01214, Lot Numbers: W07334963, W09359069, X02388473, X02396406, X05401242, and X05418353 PROFEMUR(R) NECK A/R VAR/VAL 1 SHORT, PHA01222, Lot Numbers: W09359061, X03396407, X04401231, X10420159, and X10428842 PROFEMUR(R) NECK A/R VAR/VAL 1 LONG, PHA01224, Lot Numbers: U1185241, V06215432, X01388475, X02396408, X04401232, X05418355, and X10420160 PROFEMUR(R) NECK 8DG A/R SHORT, PHA01232, Lot Numbers: V0821

    FDA Enforcement
    Class II ·Terminated·Wright Medical Technology Inc·November 7, 2012

    Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675 CENTRAL LINE INSERTION PROCEDURE KIT DT10755 DRESS UP KIT DT10850 PORT DRESSING CHANGE TRAY DT10850 PORT DRESSING CHANGE TRAY DT11300 DIALYSIS ON/OFF KIT DT11610 DRESSING CHANGE TRAY DT11955 UNIVERSAL LINE FULL BODY DRAPE KIT - REG DT12220 CVC DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12270 DRESSING CHANGE TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12415 NEONATAL PICC INSERTION TRAY DT12485 PEDI CENT LINE TRAY W/SORB SHIELD DT12540 CENTRAL LINE PACK DT12555 UNIVERSAL CVC INS SUPP TRAY DT12725 CENTRAL LINE DRESSING TRAY DT12900 CL / PICC DRESSING CHANGE TRAY DT13005A CVC DRESSING CHANGE TRAY DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13055 PICC/CENTRAL LINE DRESSING CHANGE DT13125 CENTRAL LINE TRAY DT13525 DRESSING CHANGE TRAY DT13560 PORT ACCESS TRAY DT13560 PORT ACCESS TRAY DT13560 PORT ACCESS TRAY DT13635 DRESSING CHANGE TRAY DT13725 ON/OFF KITS DT13835 DRESSING CHANGE TRAY W/BIOPATCH DT13885 DRESSING CHANGE TRAY DT14065 CVC KIT DT14100 CENTRAL LINE DSG CHG TRAY W/BIOPATCH DT14135 PICC/CVC DRSG CHNG TRAY W/SORB SHIELD DT14180 UNIVERSAL CATHETER INSERTION SET DT14215 CVC LINE DRESSING CHANGE DT14215 CVC LINE DRESSING CHANGE DT14380 PICC MAINTENANCE PACK DT14470 CVC DRSG CH W/BIOPATCH & SORB SHLD DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14500 CENTRAL LINE DRESSING CHANGE TRAY DT14650 MAXIMUM PROTECTION KIT DT14865 PORT CATH FLUSH KIT DT14965 PROCEDURE KIT DT15160 ADULT PORT FLUSH KIT DT15370 IN-PATIENT VAD KIT DT15370 IN-PATIENT VAD KIT DT15600 DRESSING CHANGE TRAY DT15605A CVC DRESSING CHANGE TRAY DT15655 CVC INSERTION TRAY DT15775 NICU PICC LINE DRESSING CHANGE KIT DT15780A PORT AND IO ACCESS DRESSING KIT DT15970 MAXIMUM PROTECTION KIT DT15970 MAXIMUM PROTECTION KIT DT15975 CENTRAL LINE INSERTION KIT DT15995 BOND CLINIC PORT DRESSING TRAY DT16435 CENTRAL LINE DRESSING KIT DT16480 PICC CENTRAL CVC CHANGE TRAY DT16550 ICU ARTERIAL LINE TRAY DT16550 ICU ARTERIAL LINE TRAY DT17055 CENTRAL LINE ACCESSORY PACK DT17120 VAD ACCESS KIT DT17135 NEONATAL DRESSING CHANGE TRAY DT17265 SUBC/PICC DRESS TRAY W/4MM BIOPATCH DT17365 SINGLE PORT ACCESS TRAY DT17380 IJ VAS-CATH DRESSING CHANGE TRAY DT17410 ON/OFF KIT & DRESSING CHANGE TRAY DT17420 ACCESS PORT KIT DT17500 PICC DRESSING KIT DT17675 DRIVELINE MANAGEMENT SYSTEM W/O BIOPATCH DT17745 DRESSING CHANGE TRAY DT17850 PORT DRESSING TRAY WITH BIOPATCH DT17870 WEEKLY DRIVELINE MANAGEMENT SYSTEM DT17965 PORT ACCESS TRAY DT18030 PORT ACCESS TRAY DT18375 DRIVELINE MANAGEMENT SYSTEM (W) DT18395 PORT ACCESS TRAY DT18415 PORT DRESSING CHANGE TRAY DT18450 PORT ACCESS DRESSING CHANGE TRAY DT18545 PORT DRESSING CHANGE TRAY DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG DT18600 DRIVELINE MANAGEMENT SYSTEM w/CHG DT18655 DAILY LVAD DRESSING KIT DT18675 LVAD MANAGEMENT SYSTEM-WEEKLY DT18690 DRIVELINE MANAGEMENT SYSTEM DT18690 DRIVELINE MANAGEMENT SYSTEM DT18695A DRIVELINE MGMT. KIT WITH SILVER ALGINATE DT18775 PORT ACCESS TRAY DT19625 PORT ACCESS TRAY DT19665 CENTRAL LINE DRESSING CHANGE KIT DT19665 CENTRAL LINE DRESSING CHANGE KIT DT19820 PEDIATRIC DRESSING CHANGE TRAY DT19835A PEDIATRIC PORT ACCESS BUNDLE DT19840 PORT ACCESS TRAY DT19900 CENTRAL LINE DRESSING CHANGE OVAL SHIELD DT20060 PORT ACCESS KIT DT20100 PORT ACCESS TRAY W/SECUREVIEW DT20160 PORT ACCESS KIT DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM DT20335 KAISER CENTRAL LINE MANAGEMENT SYSTEM DT20350A DIALYSIS OFF KIT DT20370A CVC/PORT ACCESS TRAY DT20385 CENTRAL LINE DRESSING KIT DT20405 PICU MAX BARRIER KIT DT20480 PICC AND PORT DRESSING KIT DT20570 CENTRAL LINE CARE & MAINTENANCE BUNDLE DT20640 PORT DRESSING CHANGE TRAY DT20

    FDA Enforcement
    Class II ·Terminated·Centurion Medical Products Corporation·February 12, 2020