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
82009–82032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2000
BELLEGLASS HP ENAMEL
K000530 · EBF
Sybron Dental Specialties, Inc.
Dental · 90d
Cleared May 17, 2000
ATAC PAK GLUCOSE REAGENT AND ATAC CALIBRATOR KITS
K000556 · CFR
Elan Diagnostics
Chemistry · 89d
Cleared May 17, 2000
MODIFICATION TO ENVOY PATIENT MONITOR
K000563 · MHX
Mennen Medical , Ltd.
Cardiovascular · 85d
Cleared May 17, 2000
VITA RESPONSE
K000597 · EIH
Vident
Dental · 85d
Cleared May 17, 2000
SCANDINAVIAN IVF SCIENCES AB, THAW-KIT 1
K000618 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 90d
Cleared May 17, 2000
3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE
K000690 · DRX
Minnesota Mining and Mfg. Co.
Cardiovascular · 78d
Cleared May 17, 2000
HEART 2005
K000775 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 69d
Cleared May 17, 2000
BELMONT UNIT, MODEL 2000 SERIES
K000799 · EIA
Belmont Equipment Corp.
Dental · 65d
Cleared May 17, 2000
NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P...
K000812 · IKN
Neurosoft, Inc.
Neurology · 65d
Cleared May 17, 2000
ARACHNOPHLEBECTOMY NEEDLE
K000932 · GAH
Advanced Medical Products, Inc.
General & Plastic Surgery · 55d
Cleared May 17, 2000
ULTRA CATHETER SET
K001115 · LKF
Lyco Enterprises, Inc.
Obstetrics & Gynecology · 41d
Cleared May 17, 2000
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18,...
K001222 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared May 17, 2000
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13,...
K001224 · FGE
Guidant Corp.
Gastroenterology & Urology · 30d
Cleared May 17, 2000
ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U.
K001225 · DKZ
Princeton BioMeditech Corp.
Toxicology · 30d
Cleared May 17, 2000
ALLROUND 55 LF
K001260 · EJT
J.F. Jelenko & Co., Inc.
Dental · 28d
Cleared May 17, 2000
MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW
K001308 · DQA
Agilent Technologies
Anesthesiology · 22d
Cleared May 17, 2000
AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND...
K001333 · DSI
Agilent Technologies Deutschland GmbH
Cardiovascular · 20d
Cleared May 17, 2000
MRI FASTSYSTEM RETRACTOR SYSTEM
K001339 · GAD
Omni-Tract Surgical, Div. Minn....
General & Plastic Surgery · 20d
Cleared May 17, 2000
ST/AR ST AND ARRHYTHMIA SOFTWARE
K001348 · MHX
Agilent Technologies, Inc.
Cardiovascular · 19d
Cleared May 17, 2000
CIDEX OPA SOLUTION
K001381 · MED
Advanced Sterilization Products
General Hospital · 15d
Cleared May 17, 2000
MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)
K001431 · HAW
Radionics, Inc.
Neurology · 9d
Cleared May 17, 2000
IVF 20, IVF 50, IVF 500, IVF 500 ANTIBIOTIC FREE, MODELS 2420, 2004, 2501, 2500
K991348 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 394d
Cleared May 17, 2000
AMBU NEONATE SILICONE RESUSCITATOR
K993278 · BTM
Ambu, Inc.
Anesthesiology · 230d
Cleared May 17, 2000
AXIOM MULTIPURPOSE WOUND DRAIN
K993592 · BSO
Axiom Medical, Inc.
Anesthesiology · 208d