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
124009–124032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 03, 1990
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
K902317 · LIT
Mallinckrodt Medical
Cardiovascular · 194d
Cleared Dec 03, 1990
OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER
K902367 · LIT
Vas-Cath, Inc.
Cardiovascular · 188d
Cleared Dec 03, 1990
CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS
K902475 · DXT
Cardio-Pak
Cardiovascular · 182d
Cleared Dec 03, 1990
SCHNEIDER MONORAIL-GEX(TM) GUIDEWIRE EXCHANGE CATH
K902587 · DQY
Schneider Intl., Ltd.
Cardiovascular · 174d
Cleared Dec 03, 1990
CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT
K902612 · DQX
Cordis Corp.
Cardiovascular · 173d
Cleared Dec 03, 1990
DISPOSABLE INFLATION GAUGE
K902695 · MAV
Cook Urological, Inc.
Cardiovascular · 167d
Cleared Dec 03, 1990
GENTLE HEADER
K902845 · DWE
Enhanced Perfusion Systems, Inc.
Cardiovascular · 158d
Cleared Dec 03, 1990
MEDTRONIC ANDOVER MEDICAL SAF-D-FIB MODEL 1220-002
K903018 · LDD
Medtronic Andover Medical, Inc.
Cardiovascular · 145d
Cleared Dec 03, 1990
OCHSNER 50 BIFURCATION
K903964 · DSY
Intervascular, Inc.
Cardiovascular · 97d
Cleared Dec 03, 1990
HIGH-PRESSURE CONNECTOR TUBE
K904212 · DXT
Mallinckrodt Medical
Cardiovascular · 82d
Cleared Dec 03, 1990
INFLATION/DEFLATION DEVICE
K904394 · MAV
Boston Scientific Corp
Cardiovascular · 69d
Cleared Dec 03, 1990
MODEL #210 STEALTH DEFIB PADS
K904462 · LDD
Cardiotronics, Inc.
Cardiovascular · 63d
Cleared Dec 03, 1990
PERCUTANEOUS INTRODUCER TRAY
K904608 · DQY
Thomas Medical Products, Inc.
Cardiovascular · 53d
Cleared Dec 03, 1990
HPI TRI-RADS VINYL RADIATION PROTECTION GLOVES
K905086 · IWP
Hpi, Inc.
Radiology · 19d
Cleared Nov 30, 1990
JOSLYN STEAM STERILIZER / STEAM MODERNIZATION KIT
K901147 · FLE
Joslyn Valve Corp.
General Hospital · 263d
Cleared Nov 30, 1990
CONTINUOUS VOLUME VENTILATOR MODEL LP10
K903010 · CBK
Aequitron Medical, Inc.
Anesthesiology · 142d
Cleared Nov 30, 1990
A-1107 ABUTMENT (FIXED)
K903041 · DZE
Minimatic Implant Technology
Dental · 142d
Cleared Nov 30, 1990
CURITY NERVE BLOCK TRAY
K903887 · CAZ
Kendall Healthcare Products Co....
Anesthesiology · 100d
Cleared Nov 30, 1990
FLAGEN TM FREE T4
K904539 · CEC
Cyberfluor, Inc.
Chemistry · 57d
Cleared Nov 30, 1990
MODEL LP6 VENTILATOR, MODIFICATION
K905244 · CBK
Aequitron Medical, Inc.
Anesthesiology · 10d
Cleared Nov 29, 1990
COROMETRICS MODEL 556 NEONATAL MONITOR
K900001 · DQA
Ge Medical Systems Information...
Anesthesiology · 331d
Cleared Nov 29, 1990
BIORE CP-100 CARDIOPULMONARY MONITOR
K900696 · BZC
Bicore Monitoring Systems
Anesthesiology · 289d
Cleared Nov 29, 1990
STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV
K901536 · FYA
Depuy, Inc.
General Hospital · 241d
Cleared Nov 29, 1990
JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR
K902157 · FMF
Johnson & Johnson Medical, Inc.
General Hospital · 198d