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

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175,820 results
123769–123792 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 20, 1990
ACUFIT TOTAL HIP
K904383 · KWY
Acu Med, Inc.
Orthopedic · 85d
Cleared Dec 20, 1990
FLEXIBLE ARTHROSCOPE
K904465 · HRX
Intramed Laboratories, Inc.
Orthopedic · 80d
Cleared Dec 20, 1990
VACUUM BAKE CYCLE
K904892 · DXY
Medtronic Vascular
Cardiovascular · 51d
Cleared Dec 20, 1990
PEDIATRIC AND INFANT CATH KITS
K905016 · FFH
Davol, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 20, 1990
RAICHEM CREATINE KINASE REAGENT, OPTIMIZED UV
K905084 · CGS
Reagents Applications, Inc.
Chemistry · 36d
Cleared Dec 20, 1990
RAICHEM GGT REAGENT
K905085 · JQB
Reagents Applications, Inc.
Chemistry · 36d
Cleared Dec 20, 1990
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
K905101 · DXQ
Hewlett-Packard Co.
Cardiovascular · 37d
Cleared Dec 20, 1990
LIFEPAK 9 DEFIBRILLATOR & CARDIAC MONITOR/MODIFIED
K905510 · LDD
Physio-Control Corp.
Cardiovascular · 13d
Cleared Dec 19, 1990
PERRY SV-1 HYPERBARIC VENTILATOR
K895513 · CBK
Perry Baromedical Services
Anesthesiology · 463d
Cleared Dec 19, 1990
GUARDIAN & JANITEX CONDOM/PROPHYLACTIC
K896098 · HIS
Allied Rubber Industries Sdn. Bhd.
Obstetrics & Gynecology · 425d
Cleared Dec 19, 1990
ANESTHETIC GAS CALIBRATION MIXTURE
K902754 · BXK
Liquid Air Corp.
Anesthesiology · 180d
Cleared Dec 19, 1990
MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE
K902822 · GZJ
Medical Design & Manufacturing Corp.
Neurology · 175d
Cleared Dec 19, 1990
G.E. MST 625/625II/MST 1050/1050II THREE PHASE GEN
K902985 · IZO
Electromek Diagnostic Systems, Inc.
Radiology · 176d
Cleared Dec 19, 1990
G.E. MSI 850/850II/1250 THREE PHASE GENERATORS
K902988 · IZO
Electromek Diagnostic Systems, Inc.
Radiology · 176d
Cleared Dec 19, 1990
CURITY SPINAL ANESTHESIA TRAY
K903761 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 121d
Cleared Dec 19, 1990
CYGNET CENTRAL
K903992 · HGM
Cygnet Co., Inc.
Obstetrics & Gynecology · 112d
Cleared Dec 19, 1990
SAFETY NEEDLE SHEATH
K904198 · FMI
Concord/Portex
General Hospital · 98d
Cleared Dec 19, 1990
SERIES 1990 ARGON SURGICAL LASERS, E1,E6,E14&E20A
K904342 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 89d
Cleared Dec 19, 1990
LPI MULILASE YAG/532 SURGICAL LASER SYSTEM
K904354 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 86d
Cleared Dec 19, 1990
HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS
K904610 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 69d
Cleared Dec 19, 1990
GDC-1475
K904614 · EJT
Deringer-Ney, Inc.
Dental · 69d
Cleared Dec 19, 1990
T.C.S. TOTAL CONTACT SEAT
K905013 · KNN
Fundamental Products Co.
Physical Medicine · 43d
Cleared Dec 19, 1990
DERMABRADER
K905046 · GFE
Aaron Medical Industries
General & Plastic Surgery · 41d
Cleared Dec 19, 1990
COMFORT-AIRE
K905126 · IOQ
Advanced Air Dynamics, Inc.
Physical Medicine · 35d