32 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SPSMEDICAL SPORVIEW STEAM BI
FDA 510(k)
FDA Class 2
·General Hospital
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257073445·PROTECT PATELLA TRACKING BRACE, LT, 2X
A Series
FDA UDI
Respironics, Inc.·00606959032057·BiPAP A Series, System One Humidifier, Japan
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK115151·DD tempMED are pre-colored dental milling blank...
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK111151·DD tempMED are pre-colored dental milling blank...
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089448906·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213033481·Coupling Treatment Tube for 4F Flexibles (15)
Zavation
FDA UDI
Zavation LLC·00842166181724·15mm Dilator
UCP DRUG SCREENING TEST CUPS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
MEDLINE GROUNDING PAD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PENCAN®
FDA Adverse Event
Injury
·B BRAUN MELSUNGEN AG·Product code BSP·May 6, 2025
CM TITAMAX EX IMPLANT 3.75X13
FDA Adverse Event
Injury
·NEODENT - JJGC S.A.·Product code DZE·November 8, 2017
UNK STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LZO·February 3, 2026
UNK ZCA CAGE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·February 3, 2026
UNK LINER
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 3, 2026
UNK ZCA CAGE
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·February 2, 2026
UNK HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·February 3, 2026
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - HPATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT, GK1033, AME STANDARD KIT 21-023, GK1044, KE39830 COLE, GK1047, AME STANDARD KIT 22-003, GK1063, AME STANDARD KIT 22-022, GK1068, AME STANDARD KIT 22-027, GK1071, AME STANDARD KIT 22-030, GK1083, AME STANDARD KIT 22-045, GK1094, AME STANDARD KIT 23-015, GK1096, AME STANDARD KIT 23-017, GK1101, AME STANDARD KIT 23-033, GK131, LAP CHOLE PROCEDURE PACK, GK153, TOTAL 5mm SOLUTION KIT 11, GK168, 10mm ACCESS/LIGATION/RETRIEVAL PK, GK258, AME STANDARD KIT 44, GK260, STANDARD SET 360 Z, GK307, CHOLE KIT 1, GK308, CHOLE KIT 15, GK320, CHOLE KIT 24, GK358, CHOLE KIT 22, GK360, CHOLE KIT 18, GK363, CHOLE KIT 31, GK364, CHOLE KIT 30, GK365, CHOLE KIT 28, GK368, CHOLE KIT 33, GK401, TOTAL 5mm SOLUTION KIT 41, GK402, TOTAL 5mm SOLUTION KIT 42, GK736, LAP. CHOLECYST. CLIP, GK738, STANDARD SET 112 F, GK739, STANDARD SET 397 F, GK834, K100796, GK835, KIT AME 55003, GK837, KIT K86656, GK857, KIT CHOLECYSTECTOMIE LOBBES, GK858, KIT KE284, GK861, KIT VESICULE 11MM CHA, GK874, LAP CHOLE KIT Z-THREAD, GK877, LAP CHOL KIT 5, GK878, SSMC LAP, CHOLE, KIT NO.1, GK879, SSMC LAP, CHOLE, KIT NO. 2, GK891, LAP-GALLE-SET, GK895, KIT HERES LAP CHOL 5MM, GK905, GALLKIT TORSBY SJUKHUS, GK920, K57569, GK921, K57526, GK924, K65251, GK962, LAP CHOL BOOM, GK965, URO- VARIKOCELEN+LYMPHEKTOMIESET, GK969, KIT LAP CHOL TOORENVLIET, GK980, KE78892 LAP PROSTATECTOMY 2, GK983, KIT KE 111515, GK987, LAP. CHOLE-SET LKH MURTAL, GK988, LAPCHOLE KIT ERASME VERSION 4, GK992, K8056 - KIT COLE, GK993, K116634, GK998, GALLEKIT VOSS, JK001, OLYMPUS KIT 1 (2XCTF03,1XCA500), JK003, OLYMPUS KIT 3 (2XCFF05, 1XCA500), JK004, OLYMPUS KIT 4 (2XCTR05, 1XCA500), K0880, DR. THAMES-LAP CHOLE, K0924, DR. COMPTON'S LAP CHOLE PACK, K2212, DR. MILLER LAP CHOLE KIT, K2440, LAP CHOLE KIT, K2607, BORLAND GASTRIC SLEEVE, K2640, LAP CHOLE KIT, K2656, SOUTH SUNFLOWER LAP CHOLE KIT, K2703, DR. AZAR LAP CHOLE PACK, K2705, DRS.GIROD & INGRAM LAP CHOLE PACK, K2797, LAP CHOLE PROCEDURAL PACK 1, K2903, LAP CHOLE KIT, K2922, KIT CLIP APPLIER, K2924, CLIP KIT A, K2925, CLIP KIT F, K2926, CLIP KIT F, K2927, CLIP KIT B, K2928, LAP CHOLE KIT, K2929, LAP CHOLE KIT, K2933, AM MENAT KIT # 0001, K2934, AM MENAT KIT # 0002
FDA Recall
Open, Classified
·Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa·Product code MDM·January 30, 2024
IN TOUCH ZU
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·May 14, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 23, 2014