FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
82537–82560 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 16, 2000
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GARMENTS...
K000303 · JOW
Healthcare Service and Supply
Cardiovascular · 105d
Cleared May 16, 2000
C-IT
K000520 · CCK
Bregas AB
Anesthesiology · 90d
Cleared May 16, 2000
SCANDINAVIAN IVF SCIENCES AB, SPERMRINSE -20/100
K000621 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 89d
Cleared May 16, 2000
SCANDINAVIAN IVF SCIENCES AB, FREEZE-KIT 1
K000623 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 89d
Cleared May 16, 2000
UMECO OPTIMA MULTILINE LASER SYSTEM
K000693 · GEX
Medical Laser Solutions, LLC
General & Plastic Surgery · 76d
Cleared May 16, 2000
PROVIEW MEDICAL IMAGE DISPLAY MODULE
K000770 · LLZ
Cerner Corp.
Radiology · 68d
Cleared May 16, 2000
MONET ACQUISITION SYSTEM FOR EEG AND POLYSOMNOGRAPHY
K001013 · OLV
Airsep Corp.
Neurology · 48d
Cleared May 16, 2000
OPTIVU HDVD SYSTEM
K001169 · GCJ
Optimize, Inc.
General & Plastic Surgery · 35d
Cleared May 16, 2000
ENDOPATH SURESEAL REDUCER CAP
K001220 · HET
Ethicon Endo-Surgery, Inc.
Obstetrics & Gynecology · 29d
Cleared May 16, 2000
ALL-PRO 2010
K001321 · IXW
All-Pro Imaging Corp.
Radiology · 20d
Cleared May 16, 2000
SOMNUS MODEL S2 ELECTROSURGICAL GENERATOR
K001438 · GEI
Somnus Medical Technologies, Inc.
General & Plastic Surgery · 8d
Cleared May 16, 2000
APOLLO MULTI-RACIAL REFERENCE POPULATION
K993337 · KGI
Norland Medical Systems, Inc.
Radiology · 224d
Cleared May 16, 2000
THE STRIPPER
K993699 · MQH
Mid-Atlantic Diagnostics, Inc.
Obstetrics & Gynecology · 196d
Cleared May 15, 2000
JETLITE 4000
K000078 · EBZ
J. Morita USA, Inc.
Dental · 125d
Cleared May 15, 2000
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
K000179 · KGO
Terang Nusa Sdn Bhd
General Hospital · 116d