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
123409–123432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1990
ICOR HCH 4, ICOR HCH 7
K904338 · BYD
Icor AB
Anesthesiology · 75d
Cleared Dec 04, 1990
IMPRAFLO 3500 SERIES
K904515 · CAC
Impra, Inc.
Anesthesiology · 62d
Cleared Dec 04, 1990
P AND T MEDIUM
K904773 · JTW
Gibson Laboratories, Inc.
Microbiology · 43d
Cleared Dec 04, 1990
RUBEOLA IGG ELISA TEST
K904854 · LJB
Gull Laboratories, Inc.
Microbiology · 36d
Cleared Dec 04, 1990
PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060
K904986 · JAA
Perkins Mfg. Co.
Radiology · 32d
Cleared Dec 04, 1990
ORTHO RUBELLA-M ANTIBODY ELISA TEST
K905079 · LFX
Ortho Diagnostic Systems, Inc.
Microbiology · 21d
Cleared Dec 04, 1990
SPORTS RIDER AND SHOP RIDER
K905245 · INI
National Health Services, Inc.
Physical Medicine · 13d
Cleared Dec 03, 1990
KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
K896437 · DPT
Kontron Instruments, Inc.
Cardiovascular · 389d
Cleared Dec 03, 1990
ACUSON HEARTSOUND/PULSE/RESPIRATION MODULE
K900560 · DQC
Acuson Corp.
Cardiovascular · 299d
Cleared Dec 03, 1990
AMPLATZ GOOSE-NECK SNARE
K901502 · DXE
Microvena Corp.
Cardiovascular · 249d
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