20 results
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19ms
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Sources: EU EUDAMED, US FDA
HESSBURG LIGHT GUARD
FDA 510(k)
FDA Class 1
·Ophthalmic
NAR Kit
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209120901·KIT, M-FAK - RGR - CUSTOM
Tronex International, Inc.
FDA UDI
TRONEX INTERNATIONAL, INC.·10097604853047·Glove, Exam, Vinyl, Synthetic + Memory, Powder-...
Zimmer® Segmental System
FDA UDI
Zimmer, Inc.·00889024198357·
IPL Hair Removal Device (SYL001AZ, SYL002AZ)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ACRO BIOTECH LLC RAPID BENZOYLECGONINE URINE TEST; CATALOG# MET001000
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523109494·Polyaxial Screw 8.5mm diameter 35mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523111282·Cannulated Polyaxial Screw 8.5mm diameter 35mm...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523108213·Polyaxial Screw 8.5mm diameter 35mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523107391·Polyaxial Screw 8.5mm diameter 35mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523108633·Polyaxial Screw 8.5mm diameter 35mm length for ...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523110384·Cannulated Polyaxial Screw 8.5mm diameter 35mm...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523109937·Reduction Polyaxial Screw 8.5mm diameter 35mm l...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523111732·Reduction Cannulated Polyaxial Screw 8.5mm dia...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523110834·Reduction Cannulated Polyaxial Screw 8.5mm dia...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523109050·Reduction Polyaxial Screw 8.5mm diameter 35mm l...
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FKX·May 23, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·November 30, 2012
FLUOROSCOPY STRETCHER
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV.·Product code FPO·September 21, 2010
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E 28MM ID, REF 144-28-05; b. 0 DEG ACUMATCH CONSTRAINED LINER SZ F 28MM ID, REF 144-28-06; c. 0 DEG ACUMATCH CONSTRAINED LINER SZ G 28MM ID, REF 144-28-07; d. 0 DEG ACUMATCH CONSTRAINED LINER SZ H 28MM ID, REF 144-28-08; e. 0 DEG ACUMATCH CONSTRAINED LINER SZ J 28MM ID, REF 144-28-09; f. 0 DEG ACUMATCH CONSTRAINED LINER SZ K 28MM ID, REF 144-28-10; g. 0 DEG MCS CONSTRAINED LINER 50-52 MM, 28 MM ID, REF 146-28-04; h. 0 DEG MCS CONSTRAINED LINER 54-58 MM, 28 MM ID, REF 146-28-05; i. 0 DEG MCS CONSTRAINED LINER 60-64 MM, 32MM ID, REF 146-32-06; j. O DEG ACUMATCH CONSTRAINED LINER SZ E 32MM ID, REF 144-32-05; k. O DEG ACUMATCH CONSTRAINED LINER SZ F 32MM ID, REF 144-32-06; l. O DEG ACUMATCH CONSTRAINED LINER SZ G 32MM ID, REF 144-32-07; m. O DEG ACUMATCH CONSTRAINED LINER SZ H 32MM ID, REF 144-32-08; n. O DEG ACUMATCH CONSTRAINED LINER SZ J 32MM ID, REF 144-32-09; o. O DEG ACUMATCH CONSTRAINED LINER SZ K 32MM ID, REF 144-32-10;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022