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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
71593–71616 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2003
SURGISIS NERVE CUFF
K031069 · JXI
Cook Biotech, Inc.
Neurology · 41d
Cleared May 15, 2003
BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM
K031295 · PAG
C.R. Bard, Inc.
Gastroenterology & Urology · 22d
Cleared May 15, 2003
BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH
K031332 · FTM
C.R. Bard, Inc.
General & Plastic Surgery · 17d
Cleared May 15, 2003
TPSA FLEX REAGENT CARTRIDGE
K031343 · LTJ
Dade Behring, Inc.
Immunology · 16d
Cleared May 14, 2003
COZART EIA COTININE URINE KIT
K021944 · MKU
Cozart Bioscience , Ltd.
Toxicology · 335d
Cleared May 14, 2003
COA-COMP/M, AUTOMATED BIPOLAR COAGULATOR
K023733 · GEI
Ingenjorsfirman Bjorn Bergdahl AB
General & Plastic Surgery · 189d
Cleared May 14, 2003
L600 HAIR REMOVAL
K030480 · GEX
A&M Technology
General & Plastic Surgery · 90d
Cleared May 14, 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · DPW
Terumo Cardiovascular Systems Corp.
Cardiovascular · 84d
Cleared May 14, 2003
DEPILASE TWIN YAG LASER SYSTEM
K030510 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 84d
Cleared May 14, 2003
GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM
K030512 · GCJ
Guidant Corp.
General & Plastic Surgery · 84d
Cleared May 14, 2003
HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K030549 · DQX
Guidcorp
Cardiovascular · 82d
Cleared May 14, 2003
AQUASOFT (OCUFILCON D) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT,...
K030748 · LPL
Clearlab Pte , Ltd.
Ophthalmic · 65d
Cleared May 14, 2003
GEM
K030917 · BZG
Collins Medical, Inc.
Anesthesiology · 51d
Cleared May 14, 2003
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
K031086 · GWM
Integra Neurosciences
Neurology · 37d
Cleared May 14, 2003
CODMAN BACTISEAL BARIUM STRIPED CATHETERS
K031123 · HCA
Codman & Shurtleff, Inc.
Neurology · 35d
Cleared May 14, 2003
OLYMPIC CFM 6000
K031149 · OMA
Olympic Medical Corp.
Neurology · 34d
Cleared May 14, 2003
MATRIX STRETCH RESISTANT DETACHABLE COIL
K031168 · HCG
Boston Scientific, Target
Neurology · 30d
Cleared May 14, 2003
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS...
K031277 · DQX
Jomed, Inc.
Cardiovascular · 22d
Cleared May 14, 2003
IBC FLOPUMP WITH GBS COATING
K031300 · KFM
Gish Biomedical, Inc.
Cardiovascular · 20d
Cleared May 13, 2003
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
K022834 · MHX
Ge Medical Systems Information...
Cardiovascular · 260d
Cleared May 13, 2003
INBODY AP1 BODY COMPOSITION ANALYZER
K023478 · MNW
Biospace Co.,Ltd
Gastroenterology & Urology · 209d
Cleared May 13, 2003
SYREX PRE-FILLED SYRINGE
K023740 · NZW
Excelsior Medical Corp.
General Hospital · 187d
Cleared May 13, 2003
MAHURKAR OPLUS CATHETER, MODEL 13.5 FR
K030209 · MPB
The Kendall Company
Gastroenterology & Urology · 112d
Cleared May 13, 2003
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
K031037 · DWF
Medtronic Perfusion Systems
Cardiovascular · 42d