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
94033–94056 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1997
FOTONA SKINSCAN
K970757 · GEX
Medical Laser Solutions
General & Plastic Surgery · 67d
Cleared May 09, 1997
OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K970779 · LZN
Osteonics Corp.
Orthopedic · 66d
Cleared May 09, 1997
T-RX RETRIEVAL FORCEPS
K970982 · OCZ
Tri-Med Specialties, Inc.
Gastroenterology & Urology · 52d
Cleared May 09, 1997
PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT
K971048 · FTM
Bio-Vascular, Inc.
General & Plastic Surgery · 49d
Cleared May 09, 1997
UNIKA
K971327 · HQY
Eyewear Partners Co.
Ophthalmic · 29d
Cleared May 09, 1997
ECLIPSE 400 MANUALLY OPERATED WHEELCAIR
K971389 · IOR
Pdg Product Design Group, Inc.
Physical Medicine · 25d
Cleared May 08, 1997
STERITEC INTEGRAPH MODEL CI-101
K960441 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 462d
Cleared May 08, 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 210d
Cleared May 08, 1997
ACROMED PEDICLE SCREW
K965102 · MNH
Acromed Corp.
Orthopedic · 139d
Cleared May 08, 1997
EMPOWER ANTERIOR DIRECT SCREWS
K965224 · KWP
Smith & Nephew Richards, Inc.
Orthopedic · 129d
Cleared May 08, 1997
DUKAL NON ADHERENT DRESSING
K970455 · EFQ
Dukal Corp.
General & Plastic Surgery · 91d
Cleared May 08, 1997
DUKAL ABD COMBINE PAD
K970457 · EFQ
Dukal Corp.
General & Plastic Surgery · 91d
Cleared May 08, 1997
EVT ANGIOSCALE ANGIOGRAPHIC CATHETER
K970469 · DQO
Guidant Cardiac and Vascular Surgery
Cardiovascular · 90d
Cleared May 08, 1997
DASH 1000 PATIENT MONITOR
K970545 · DSI
Marquette Medical Systems, Inc.
Cardiovascular · 85d
Cleared May 08, 1997
DERMAMEND FOAM ISLAND DRESSING
K970600 · KMF
Dermarx Corp.
General & Plastic Surgery · 79d
Cleared May 08, 1997
UNITRON MODEL SOUND F/X CIC
K970692 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 72d
Cleared May 08, 1997
VAPOR-TECH SLED ELECTRODE
K970717 · FAS
Northgate Technologies, Inc.
Gastroenterology & Urology · 70d
Cleared May 08, 1997
DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111
K970813 · LLZ
Denvu, Inc.
Radiology · 64d
Cleared May 08, 1997
RESOLUT REGENERATIVE MATERIAL
K970884 · LYC
W.L. Gore & Associates, Inc.
Dental · 59d
Cleared May 08, 1997
ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM
K971196 · DZE
Innova Corp.
Dental · 38d
Cleared May 08, 1997
EZ SURE (EXCEL) URINE MIDSTREAM PREGNANCY HOME TEST
K971286 · LCX
Excel Scientific, Inc.
Chemistry · 31d
Cleared May 08, 1997
SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
K971287 · DKB
Beckman Instruments, Inc.
Toxicology · 31d
Cleared May 08, 1997
CENTRE-DRIVE DRILL-FREE SCREW
K971297 · HRS
KLS-Martin L.P.
Orthopedic · 30d
Cleared May 08, 1997
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS
K971317 · KDD
National Healthcare Mfg. Corp.
General & Plastic Surgery · 29d