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
71089–71112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 11, 2003
PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
K031366 · MOS
Usa Instruments, Inc.
Radiology · 72d
Cleared Jul 11, 2003
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
K031417 · DQY
Intra Luminal Therapeutics, Inc.
Cardiovascular · 67d
Cleared Jul 11, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE
K031589 · LON
Becton, Dickinson & CO
Microbiology · 51d
Cleared Jul 11, 2003
MODIFICATION TO HERMES O.R. CONTROL CENTER
K031720 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 38d
Cleared Jul 11, 2003
MEDRAD SWABBABLE VALVE TRANSFER SET
K031808 · FPK
Medrad, Inc.
General Hospital · 29d
Cleared Jul 11, 2003
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K031823 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Jul 11, 2003
GEMINI 16
K032036 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 10d
Cleared Jul 10, 2003
COACH 888W
K030760 · ITI
Wheelchair & Scooter Express
Physical Medicine · 121d
Cleared Jul 10, 2003
4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX,...
K030852 · DRF
Mogul Enterprises
Cardiovascular · 114d
Cleared Jul 10, 2003
GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S...
K031036 · MLY
Gebauer Co.
Physical Medicine · 100d
Cleared Jul 10, 2003
AEROLET TOILET LIFT, MODEL AER-01
K031045 · INO
Economic Holland B.V.
Physical Medicine · 71d
Cleared Jul 10, 2003
IVD CRYPTOSPORIDIUM ANTIGEN DETECTION ASSAY, MODEL CP-96
K031059 · MHJ
Ivd Research, Inc.
Microbiology · 104d
Cleared Jul 10, 2003
EBI XFIX OPTIROM KNEE FIXATOR
K031093 · KTT
Ebi, L.P.
Orthopedic · 94d
Cleared Jul 10, 2003
RH-900
K031115 · KTB
Iomed, Inc.
Physical Medicine · 93d
Cleared Jul 10, 2003
BODY SIGNAL ECG ELECTRODE
K031174 · DRX
Wandy Rubber Industrial Co., Ltd.
Cardiovascular · 87d
Cleared Jul 10, 2003
JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II
K031342 · ITI
Jason Marine Enterprises, Inc.
Physical Medicine · 73d
Cleared Jul 10, 2003
VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE
K031410 · LON
bioMerieux, Inc.
Microbiology · 66d
Cleared Jul 10, 2003
CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE,...
K031482 · GXH
Cryomedical Instruemts , Ltd.
Neurology · 59d
Cleared Jul 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML
K031530 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared Jul 10, 2003
SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE
K031716 · MQX
Asia-Med GmbH and CO KG
General Hospital · 37d
Cleared Jul 10, 2003
X-PROT DUO PORT
K032044 · LJT
C.R. Bard, Inc.
General Hospital · 8d
Cleared Jul 09, 2003
DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135,...
K030638 · FGE
Avantec Vascular Corp.
Gastroenterology & Urology · 131d
Cleared Jul 09, 2003
ENTERALITE INFINITY ENTERAL FEEDING PUMP
K031199 · LZH
Zevex Intl., Inc.
General Hospital · 86d
Cleared Jul 09, 2003
TELZUIT CARDIAC MONITORING SYSTEM
K031229 · DXH
Telzuit Technologies, Inc.
Cardiovascular · 82d