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
110065–110088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1994
END-IRRIGATING ENDOILLUMINATOR
K931546 · FST
Infinitech, Inc.
General & Plastic Surgery · 317d
Cleared Feb 09, 1994
NU-GEL ISLAND WOUND DRESSING
K932336 · NAE
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 271d
Cleared Feb 09, 1994
THEREX LOW-PROFILE PORT .6MM I.D 2.3MM O.D.
K932447 · LJT
Therex Corp.
General Hospital · 265d
Cleared Feb 09, 1994
SPYROGEL WOUND DRESSING
K932457 · KGX
Polymint Industrial Co. , Ltd.
General & Plastic Surgery · 264d
Cleared Feb 09, 1994
SPORTS MEDICINE QUADRATURE SHOULDER COIL
K932552 · LNH
Magnetic Research, Inc.
Radiology · 259d
Cleared Feb 09, 1994
CANDELA PLTL-1 LASER SYSTEM
K933016 · GEX
Candela Laser Corp.
General & Plastic Surgery · 233d
Cleared Feb 09, 1994
MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR
K933122 · JTY
Bioclinical Systems, Inc.
Microbiology · 229d
Cleared Feb 09, 1994
MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES
K933294 · FPB
Aesculap, Inc.
General Hospital · 217d
Cleared Feb 09, 1994
REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG
K933390 · FPA
Pharmacia Deltec, Inc.
General Hospital · 212d
Cleared Feb 09, 1994
CRITIKON CENTRAL STATIN MONITOR
K933404 · DPS
Critikon Company, LLC
Cardiovascular · 212d
Cleared Feb 09, 1994
R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260
K933687 · FKX
R & D Batteries, Inc.
Gastroenterology & Urology · 195d
Cleared Feb 09, 1994
POWERMATIC EXAMINATION TABLE
K933727 · INQ
Hausmann Industries, Inc.
Physical Medicine · 191d
Cleared Feb 09, 1994
S.S.C. MEDICAL MODEL 5000 SERIES BED
K934090 · FNL
Super Sagless Corp.
General Hospital · 169d
Cleared Feb 09, 1994
CONTAIN-OR
K934215 · KKX
Dlp, Inc.
General Hospital · 163d
Cleared Feb 09, 1994
SUNGLASSES
K934277 · HQY
Rainbow Optics, Inc.
Ophthalmic · 162d
Cleared Feb 09, 1994
BACT/ALERT 120
K934593 · MDB
Organon Teknika Corp.
Microbiology · 138d
Cleared Feb 09, 1994
JOBST ATHROMBIC PUMP - SYSTEM 2500
K934639 · JOW
Jobst Institute, Inc.
Cardiovascular · 133d
Cleared Feb 09, 1994
KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION
K934647 · FJL
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 133d
Cleared Feb 09, 1994
WALLACH ULTRA FREEZE
K935010 · GEH
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 112d
Cleared Feb 09, 1994
ARTISAN PROGRAMMER & HEARING AID
K935048 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 111d
Cleared Feb 09, 1994
INCREASED SAR PACKAGE FOR MRT-150A
K935084 · LNH
Toshiba America Mri, Inc.
Radiology · 107d
Cleared Feb 09, 1994
VISIONLINK ACR-NEMA CONVERSION UTILITIES
K935103 · LMD
Evergreen Technologies, Inc.
Radiology · 107d
Cleared Feb 09, 1994
ODYSSEY CLINICAL AUDIOMETER
K935348 · EWO
Qualitone
Ear, Nose, Throat · 96d
Cleared Feb 09, 1994
E-Z PREP(R) TRAY WITH HIBICLENS(R)
K935483 · LRO
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 86d