FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73585–73608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K023324 · KTT
Ebi, L.P.
Orthopedic · 14d
Cleared Oct 17, 2002
DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414
K012816 · FRO
Dynarex Corp.
General & Plastic Surgery · 421d
Cleared Oct 17, 2002
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
K013921 · FAD
Porges S.A.
Gastroenterology & Urology · 324d
Cleared Oct 17, 2002
BIOSTEON CROSS PIN
K021351 · HWC
Biocomposites, Ltd.
Orthopedic · 171d
Cleared Oct 17, 2002
SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS
K021815 · HAW
Smith & Nephew, Inc.
Neurology · 136d
Cleared Oct 17, 2002
BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
K021835 · FTL
Brennen Medical, Inc.
General & Plastic Surgery · 135d
Cleared Oct 17, 2002
PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX,...
K021856 · EYB
Porges S.A.
Gastroenterology & Urology · 133d
Cleared Oct 17, 2002
GMRS PRESS FIT STEMS WITH PUREFIX HA
K022403 · LZO
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Oct 17, 2002
WILSON-COOK CYSTOTOME
K022595 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 73d
Cleared Oct 17, 2002
HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT
K022651 · LXT
Howmedica Osteonics Corp.
Orthopedic · 69d
Cleared Oct 17, 2002
CARRAKLENZ AND ULTRAKLENZ
K022670 · FRO
Carrington Laboratories, Inc.
General & Plastic Surgery · 66d
Cleared Oct 17, 2002
ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X...
K022824 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 52d
Cleared Oct 17, 2002
SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)
K022924 · IOR
Otto Back Healthcare, LP
Physical Medicine · 43d
Cleared Oct 17, 2002
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
K023085 · JDI
Biomet Orthopedics, Inc.
Orthopedic · 30d
Cleared Oct 17, 2002
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
K023186 · JWH
Exactech, Inc.
Orthopedic · 23d
Cleared Oct 17, 2002
OSSTAPLE
K023203 · JDR
Biomedical Ent., Inc.
Orthopedic · 22d
Cleared Oct 17, 2002
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
K023211 · JWH
Zimmer, Inc.
Orthopedic · 21d
Cleared Oct 17, 2002
LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR THE BECKMAN-COULTER...
K023250 · JJY
Cliniqa Corporation
Chemistry · 17d
Cleared Oct 17, 2002
SAS STREPALERT
K023270 · GTY
Sa Scientific, Inc.
Microbiology · 16d
Cleared Oct 17, 2002
COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · GEI
Boston Scientific Corp
General & Plastic Surgery · 15d
Cleared Oct 16, 2002
SANARUS INDICA MARKER SYSTEM
K020054 · FZP
Sanarus Medical, Inc.
General & Plastic Surgery · 281d
Cleared Oct 16, 2002
SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)
K021889 · KKY
Surgical Technology Laboratories, Inc.
General & Plastic Surgery · 131d
Cleared Oct 16, 2002
MOIST PUNCTAL PLUG SYSTEM
K021936 · LZU
Moist Medical, Inc.
Ophthalmic · 126d
Cleared Oct 16, 2002
NOVUS SPECTRA
K022327 · GEX
Lumenis, Inc.
General & Plastic Surgery · 90d