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
74569–74592 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 2002
DATEX-OHMEDA HMEF 500
K021265 · CAH
Datex-Ohmeda
General Hospital · 130d
Cleared Aug 30, 2002
ENDOSSEOUS IMPLANT
K021355 · DZE
Branemark Integration AB
Dental · 123d
Cleared Aug 30, 2002
ANDERSEN NASOGASTRIC TUBE WITH STYLET, MODELS AN 11S, 13S, 14S & 18S
K021493 · KNT
Andersen Products, Inc.
Gastroenterology & Urology · 113d
Cleared Aug 30, 2002
EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE...
K021781 · CGA
Chay Medical, LLC
Chemistry · 92d
Cleared Aug 30, 2002
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
K021837 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 87d
Cleared Aug 30, 2002
ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM
K022543 · FAS
Arthrocare Corp.
Gastroenterology & Urology · 29d
Cleared Aug 30, 2002
HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
K022563 · MQP
Implex Corp.
Orthopedic · 28d
Cleared Aug 30, 2002
INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
K022564 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 28d
Cleared Aug 30, 2002
PVP (POLYVINYLPYRROLIDONE)
K022590 · MQL
Intl., Inc.
Obstetrics & Gynecology · 25d
Cleared Aug 30, 2002
RANDOX LIPID CONTROL
K022591 · JJY
Randox Laboratories, Ltd.
Chemistry · 25d
Cleared Aug 30, 2002
MODIFICATION TO THE MAESTRO SYSTEM
K022795 · NHA
BioHorizons Implant Systems, Inc.
Dental · 7d
Cleared Aug 29, 2002
WS-501 HEAT LAMP
K013197 · ILY
Lhasa Medical, Inc.
Physical Medicine · 338d
Cleared Aug 29, 2002
ALPHACOR
K013756 · HQM
Argus Biomedical Pty, Ltd.
Ophthalmic · 289d
Cleared Aug 29, 2002
ABR-2000
K020360 · GZO
Meridian Co., Ltd.
Neurology · 206d
Cleared Aug 29, 2002
NONCOR INFUSION SETS
K021080 · FPA
Cardio Med Supplies, Inc.
General Hospital · 148d
Cleared Aug 29, 2002
GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM
K021807 · OLV
Grass Instrument Co.
Neurology · 87d
Cleared Aug 29, 2002
HARMAC HUBER NEEDLE SAFETY DEVICE, H2984001
K021916 · FPA
Harmac Medical Products, Inc.
General Hospital · 79d
Cleared Aug 29, 2002
MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
K021988 · FRN
Medrad, Inc.
General Hospital · 72d
Cleared Aug 29, 2002
NARKOMED MRI-2 ANESTHESIA SYSTEM, MODEL NM-MRI-2
K022031 · BSZ
Draeger Medical, Inc.
Anesthesiology · 69d
Cleared Aug 29, 2002
ACETAL
K022032 · EHP
Inovativ, LLC
Dental · 69d
Cleared Aug 29, 2002
SAFEPRO SAFETY SYRINGE
K022063 · MEG
Formosa Medical Devices, Inc.
General Hospital · 65d
Cleared Aug 29, 2002
JENSEN GOLD FOIL
K022206 · EJT
Jensen Industries, Inc.
Dental · 55d
Cleared Aug 29, 2002
FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS
K022260 · LGM
Isolation Systems, Inc.
General Hospital · 62d
Cleared Aug 29, 2002
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF UNWANTED HAIR
K022568 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 27d