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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
149545–149568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 22, 1985
C/PES 9201, ECG STRESS TESTING SYS
K850114 · DRT
Gould, Inc.
Cardiovascular · 39d
Cleared Feb 22, 1985
THERMAL DIFFUSION CEREBRAL BLOOD FLOW MONITOR
K850657 · LME
Flowtronics, Inc.
Neurology · 25d
Cleared Feb 21, 1985
LEUKOFIX R
K843873 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 142d
Cleared Feb 21, 1985
LEUKOPOR SURGICAL TAPE
K843874 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 142d
Cleared Feb 21, 1985
LEUKOSILK
K843875 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 142d
Cleared Feb 21, 1985
LEUKOFLEX SURGICAL TAPE
K843876 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 142d
Cleared Feb 21, 1985
S.E.T. TUBE
K843988 · BTR
Bfw Laboratories, Inc.
Anesthesiology · 133d
Cleared Feb 21, 1985
CPNOGARD CAPNOMETER 1250
K844010 · CCK
Novametrix Medical Systems, Inc.
Anesthesiology · 132d
Cleared Feb 21, 1985
X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY
K844337 · IYB
Quality X-Ray Manufacturing, Inc.
Radiology · 105d
Cleared Feb 21, 1985
HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE
K844372 · GEI
Consolidated Medical Equipment, Inc.
General & Plastic Surgery · 100d
Cleared Feb 21, 1985
INDEPENDENT JAW MODE OPTION FOR VARIAN CLINAC 4/10
K844424 · JAD
Varian Assoc., Inc.
Radiology · 98d
Cleared Feb 21, 1985
THE PROBE 100
K844466 · IPF
Rich-Mar Corp.
Physical Medicine · 94d
Cleared Feb 21, 1985
TRACTION ACCESSORIES
K844490 · ILZ
Jerome Medical
Physical Medicine · 93d
Cleared Feb 21, 1985
BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG
K844554 · IWZ
Belmont Equipment Corp.
Radiology · 92d
Cleared Feb 21, 1985
BOVIE X-10 ELECTROSURGICAL GENERATOR(UNIT)
K844565 · GEI
Clinical Technology Corp.
General & Plastic Surgery · 90d
Cleared Feb 21, 1985
WHEELCHAIRS
K844574 · IOR
Medicon, Inc.
Physical Medicine · 90d
Cleared Feb 21, 1985
PENNINE GUEDEL AIRWAY 00,0,1,2,3 & 4
K844873 · CAE
Pennine Medical , Ltd.
Anesthesiology · 66d
Cleared Feb 21, 1985
MARTANIQUE 6-TUBE HOME SOLARIUM
K845001 · FTC
Bainbridge Trading Co., Ltd.
General & Plastic Surgery · 57d
Cleared Feb 21, 1985
BROOKER ACETABULAR CUP
K845005 · JDI
Biomet, Inc.
Orthopedic · 57d
Cleared Feb 21, 1985
CAPD STAGED CONNECTOR
K845041 · FKO
Abbott Laboratories
Gastroenterology & Urology · 55d
Cleared Feb 21, 1985
P-3 CLOSING INSTRUMENT
K850041
Lone Star Medical Products, Inc.
General & Plastic Surgery · 45d
Cleared Feb 21, 1985
INSTRUMENT POCKET
K850063
E.M. Adams
General & Plastic Surgery · 44d
Cleared Feb 21, 1985
PANAMEDIC GAUZE SPONGES
K850093 · EFQ
General Electric Trading Co.
General & Plastic Surgery · 41d
Cleared Feb 21, 1985
SONI-LOK SCOPE STABILIZER
K850122 · FXR
Med Surg Designs, Inc.
General & Plastic Surgery · 38d