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
90649–90672 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1998
ULTRACON ULTRAFILTRATOR
K971710 · FJI
Quantic Biomedical, Inc.
Gastroenterology & Urology · 295d
Cleared Feb 27, 1998
NT2000
K972244 · GZJ
Bio-Medical Research, Ltd.
Neurology · 256d
Cleared Feb 27, 1998
S3 MAST PUMP
K972321 · DWB
Stoeckert Instrumente
Cardiovascular · 249d
Cleared Feb 27, 1998
FASTDAM
K972775 · EIE
Interdent, Inc.
Dental · 218d
Cleared Feb 27, 1998
FIRE STICK
K973197 · GEI
H.S. Intl. Co., Inc.
General & Plastic Surgery · 185d
Cleared Feb 27, 1998
KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
K973409 · KNT
Davis & Geck, Inc.
Gastroenterology & Urology · 171d
Cleared Feb 27, 1998
THE MEHDIAN LUMBO-SACRAL PEDICLE SCREW SYSTEM
K973425 · MNH
Corin USA
Orthopedic · 170d
Cleared Feb 27, 1998
BIOSCREW ABSORBABLE INTERFERENCE SREW
K973758 · HWC
Linvatec Corp.
Orthopedic · 148d
Cleared Feb 27, 1998
KSEA ENDOTIP SYSTEM
K973909 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 136d
Cleared Feb 27, 1998
FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE
K974067 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 123d
Cleared Feb 27, 1998
THE PERFORMANCE PLUS CONFIDENCE RINGS, THE PERFORMANCE PLUS ERECTION INDUCER...
K974082 · LKY
Performance Plus, Inc.
Gastroenterology & Urology · 121d
Cleared Feb 27, 1998
EPS
K974504 · LLZ
E For M Imaging Systems Div.,...
Radiology · 88d
Cleared Feb 27, 1998
LSF HA COATED TRIAD TOTAL HIP SYSTEM
K974506 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 88d
Cleared Feb 27, 1998
OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
K974556 · JWH
Osteonics Corp.
Orthopedic · 84d
Cleared Feb 27, 1998
PERITONEAL DIALYSIS CATHETER CONNECTOR
K974570 · FKO
Medigroup, Inc.
Gastroenterology & Urology · 81d
Cleared Feb 27, 1998
3.25MM SIMPLER THREADED DENTAL IMPLANT
K974856 · DZE
Vancouver Implant Resources, Inc.
Dental · 60d
Cleared Feb 27, 1998
4.0MM SIMPLER THREADED DENTAL IMPLANT
K974857 · DZE
Vancouver Implant Resources, Inc.
Dental · 60d
Cleared Feb 27, 1998
CYNOSURE PHOTOGENICA 532 LASER
K974900 · GEX
Cynosure, Inc.
General & Plastic Surgery · 59d
Cleared Feb 27, 1998
MENTOR SKIN PROTECTION PAD
K980050 · GCJ
Mentor Corp.
General & Plastic Surgery · 52d
Cleared Feb 27, 1998
SLT SELECT FIBER DELIVERY SYSTEM AND CONTACT TIPS
K980156 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 42d
Cleared Feb 27, 1998
DERMASENSE PLUS DISPERSIVE ELECTRODE
K980171 · GEI
Horizon Medical, Inc.
General & Plastic Surgery · 38d
Cleared Feb 27, 1998
MSB TENS ELECTRODES (DISPOSABLE)
K980229 · GXY
Msb , Ltd.
Neurology · 36d
Cleared Feb 27, 1998
WELCH ALLYN XENON 300 LIGHT SOURCE
K980281 · GCT
Welch Allyn, Inc.
Gastroenterology & Urology · 32d
Cleared Feb 27, 1998
AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240
K980366 · GEI
Aaron Medical Industries
General & Plastic Surgery · 29d