FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
103417–103440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 1995
ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES
K950592 · HRX
Eare Consulting Service
Orthopedic · 112d
Cleared Jun 01, 1995
ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
K950727 · CGA
Lifescan, Inc.
Chemistry · 105d
Cleared Jun 01, 1995
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKMAN ARRAY 360 SYSTEM
K950802 · JJY
International Enzymes, Inc.
Immunology · 100d
Cleared Jun 01, 1995
HEP-2000 COLORZYME ANA-RO TEST SYSTEM
K950979 · DHN
Immuno Concepts, Inc.
Immunology · 90d
Cleared Jun 01, 1995
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION
K951058 · CFR
Heraeus Kulzer, Inc.
Chemistry · 86d
Cleared Jun 01, 1995
GORE SMOOTHER GUIDED RASP
K951163 · HRX
W.L. Gore & Associates, Inc.
Orthopedic · 79d
Cleared Jun 01, 1995
SHARPLAN MODEL 712 ACUSPOT MICROMANIPULATOR
K951204 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 76d
Cleared Jun 01, 1995
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS...
K951319 · DOE
Roche Diagnostic Systems, Inc.
Toxicology · 70d
Cleared Jun 01, 1995
HLT 406
K951382 · INQ
Health Care Mfg., Inc.
Physical Medicine · 66d
Cleared Jun 01, 1995
TEMPRA HEAT PACK
K951383 · IMD
Tempra Technology, Inc.
Physical Medicine · 66d
Cleared Jun 01, 1995
DUPONT ACA DIGOXIN (DGN A) METHOD
K951441 · KXT
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 64d
Cleared Jun 01, 1995
EMIT 2000 DIGOXIN ASSAY
K951755 · KXT
Syva Co.
Chemistry · 45d
Cleared Jun 01, 1995
STABILOR NF IV
K951780 · EJT
Degussa Corp.
Dental · 48d
Cleared Jun 01, 1995
STABILOR G
K951782 · EJT
Degussa Corp.
Dental · 48d
Cleared Jun 01, 1995
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
K951966 · JZJ
Kent Laboratories, Inc.
Immunology · 35d
Cleared Jun 01, 1995
IMMUNOASSAY DRUGS OF ABUSE CONTROLS
K952056 · DIF
Medi-Tech, Inc.
Toxicology · 30d
Cleared Jun 01, 1995
TBN-TIPPED OPTICAL FIBER
K952113 · GEX
Myriad Lase, Inc.
General & Plastic Surgery · 27d
Cleared Jun 01, 1995
MEDICAL MIXTURE-LASER GAS MIXTURES
K952162 · GEX
Standard Welders Supply Co.
General & Plastic Surgery · 24d
Cleared Jun 01, 1995
LASER GAS MIXTURE
K952301 · GEX
Airgas Management, Inc.
General & Plastic Surgery · 16d
Cleared Jun 01, 1995
DYNABITE UROLOGICAL FORCEPS
K952391 · FCL
Portlyn Corp.
Gastroenterology & Urology · 10d
Cleared May 31, 1995
OSTEOGEN (HA RESORB)
K923310 · LYC
Impladent
Dental · 1058d
Cleared May 31, 1995
HRT SERIES 100 ELECTROPHYSIOLOGY CATHETER
K932388 · DRF
Heart Rhythm Technologies, Inc.
Cardiovascular · 744d
Cleared May 31, 1995
BRYAN POSTERIOR SPINAL FIXATOR (BPSF)
K945435 · KWP
Arcan Orthopaedic Corp.
Orthopedic · 236d
Cleared May 31, 1995
CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE
K945589 · JWH
U.S. Medical Products, Inc.
Orthopedic · 198d