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
115633–115656 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1992
SHARPE ENDODISSECTOR
K921888 · HET
Paladin Medical, Inc.
Obstetrics & Gynecology · 182d
Cleared Oct 20, 1992
VISITEC MICROSURGICAL SUTURE
K922530 · GAR
Visitec Co.
General & Plastic Surgery · 145d
Cleared Oct 20, 1992
DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE
K922604 · IYO
Biodan Medical Systems, Ltd.
Radiology · 140d
Cleared Oct 20, 1992
TRENDELENBURG ULTRASOUND TABLE, MODEL # 056-603
K922605 · IYO
Biodan Medical Systems, Ltd.
Radiology · 140d
Cleared Oct 20, 1992
MOPYLEN
K922630 · GAW
S. Jackson, Inc.
General & Plastic Surgery · 139d
Cleared Oct 20, 1992
FUNGI FLUOR KIT
K923349 · LYF
Polysciences, Inc.
Microbiology · 104d
Cleared Oct 20, 1992
AMK MODULAR POROUS COATED TITANIUM TIBIAL TRAY
K923451 · JWH
Depuy, Inc.
Orthopedic · 98d
Cleared Oct 20, 1992
QUADRASORB FILTER
K923661 · CAH
Union Broach, Div. Moyco Industries,...
General Hospital · 90d
Cleared Oct 20, 1992
ELTRAX OPTICAL DISK IMAGE ARCHIVING SYSTEM
K923680 · LMB
Minnetonka Medical
Radiology · 90d
Cleared Oct 20, 1992
MINI HEART
K923690 · CAF
B&B Medical Technologies, Inc.
Anesthesiology · 88d
Cleared Oct 20, 1992
R-MADE HEAD/ARM SUPPORT
K923775 · IXQ
R-Made, Inc.
Radiology · 84d
Cleared Oct 20, 1992
DISLODGER, STONE, BASKET, URETERAL, METAL
K924027 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Oct 20, 1992
NICKI, MODEL NUMBER USD-NK-UP1
K924086 · FAP
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 68d
Cleared Oct 20, 1992
TIMEOSCOPE AND FLEXISCOPE
K924095 · LDE
Stethoscopes of America, Inc.
Cardiovascular · 68d
Cleared Oct 19, 1992
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · KKX
Trinity Laboratories, Inc.
General Hospital · 271d
Cleared Oct 19, 1992
DRESSING CHANG & WOUND MANAGEMENT
K920480 · FRG
Cypress Medical Products, Ltd.
General Hospital · 264d
Cleared Oct 19, 1992
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K920774 · DTN
Medtronic Vascular
Cardiovascular · 242d
Cleared Oct 19, 1992
HSG TRAY
K920803 · HIB
Unimar, Inc.
Obstetrics & Gynecology · 241d
Cleared Oct 19, 1992
SURGICAL INSTRUMENT KIT, DISPOSABLE
K920989 · KDD
Ulti-Med Intl., Inc.
General & Plastic Surgery · 231d
Cleared Oct 19, 1992
EDGE MEDICAL DISPENSING PIN
K921031 · LHI
Edgewater Medical Center
General Hospital · 230d
Cleared Oct 19, 1992
PLATELIN L
K921396 · GFO
Organon Teknika Corp.
Hematology · 210d
Cleared Oct 19, 1992
LSPI INFANT BAG MASK
K921553 · BTM
Life Support Products, Inc.
Anesthesiology · 201d
Cleared Oct 19, 1992
STRATUS BHCG FLUOROMETRIC ENZYME IMMUNOASSAY
K922073 · DHA
Baxter Diagnostics, Inc.
Chemistry · 168d
Cleared Oct 19, 1992
INTERLINK(TM) INJECTION SITE
K922558 · FPA
Baxter Healthcare Corp
General Hospital · 144d