FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91681–91704 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1997
IMAGE FUSION AND REVIEW SYSTEM
K973233 · KPS
Adac Laboratories
Radiology · 89d
Cleared Nov 25, 1997
LEG'MAP OPTION
K973270 · IZI
Ge Medical Systems, Inc.
Radiology · 84d
Cleared Nov 25, 1997
IMATION MODEL 9410 NETWORK INTERFACE
K973303 · LMD
Imation Corp.
Radiology · 83d
Cleared Nov 25, 1997
ARTICULATE FITTING SYSTEM
K973320 · EWO
Decibel Instruments, Inc.
Ear, Nose, Throat · 83d
Cleared Nov 25, 1997
ID. STORE (RELEASE 2.0)
K973413 · LMB
I.S.G. Technologies, Inc.
Radiology · 77d
Cleared Nov 25, 1997
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
K973541 · EBC
Medental Intl.
Dental · 68d
Cleared Nov 25, 1997
ABBOTT AXSYM TROPONIN-I
K974103 · MMI
Abbott Laboratories
Chemistry · 25d
Cleared Nov 24, 1997
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 419d
Cleared Nov 24, 1997
VERY PRIVATE INTIMATE MOISTURE
K971793 · HIS
Brandwynne Corp.
Obstetrics & Gynecology · 193d
Cleared Nov 24, 1997
PERIPHERALLY INSERTED CENTRAL
K971999 · LJS
B.Braun Medical, Inc.
General Hospital · 178d
Cleared Nov 24, 1997
NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT
K972270 · JWH
Zimmer, Inc.
Orthopedic · 166d
Cleared Nov 24, 1997
SENDAX MDI (MINI DENTAL IMPLANT)
K972351 · DZE
Sendax Mdic Management, Inc.
Dental · 153d
Cleared Nov 24, 1997
CHARTERMED TPN-EVA BAGS
K973103 · KPE
Chartermed, Inc.
General Hospital · 97d
Cleared Nov 24, 1997
FLUORO-TEX SURGICAL MEMBRANE
K973178 · DXZ
Bridger Biomed, Inc.
Cardiovascular · 91d
Cleared Nov 24, 1997
WILSON-COOK STRICTURE MEASURING CATHETER
K973205 · ODD
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 24, 1997
BOSTON LIQUID ENZYMATIC CLEANER
K973217 · LPN
Polymer Technology Corp.
Ophthalmic · 89d
Cleared Nov 24, 1997
KARL STORZ DIRECT COUPLED CAMERA HEAD
K973252 · FET
Karl Storz Imaging, Inc.
Gastroenterology & Urology · 87d
Cleared Nov 24, 1997
J-TIP INJECTOR
K973254 · KZE
National Medical Products, Inc.
General Hospital · 87d
Cleared Nov 24, 1997
WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD
K973261 · LZO
Whiteside Biomechanics, Inc.
Orthopedic · 87d
Cleared Nov 24, 1997
EXTEND HIP STEM
K973296 · JDI
Wrightmedicaltechnologyinc
Orthopedic · 83d
Cleared Nov 24, 1997
PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM
K973359 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 77d
Cleared Nov 24, 1997
CERTODYN RAECG UNIVERSAL ADAPTER
K973371 · DQY
B.Braun Medical, Inc.
Cardiovascular · 77d
Cleared Nov 24, 1997
SOFTFORM FACIAL IMPLANT
K973462 · FTL
Tissue Technologies, Inc.
General & Plastic Surgery · 73d
Cleared Nov 24, 1997
VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS)
K973558 · FEB
Ultracell Medical Technologies, Inc.
General Hospital · 66d