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
74065–74088 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 29, 2002
PROLITE/PLASMALITE MPX PULSED LIGHT SYSTEM FOR TREATMENT OF VASCULAR LESIONS
K022569 · GEX
Medical Bio Care Sweden AB
General & Plastic Surgery · 27d
Cleared Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
K022654 · JHY
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Aug 28, 2002
APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER
K013003 · FRG
Advanced Sterilization Products
General Hospital · 356d
Cleared Aug 28, 2002
SR IVOCRON
K013869 · EBG
Ivoclar Vivadent, Inc.
Dental · 280d
Cleared Aug 28, 2002
RADIOSYSTEM/NT, MODEL 80-13020
K020320 · IYE
Styker Instruments
Radiology · 209d
Cleared Aug 28, 2002
PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
K020550 · DSI
Datascope Corp.
Cardiovascular · 190d
Cleared Aug 28, 2002
INTROCAN SAFETY IV CATHETER
K020785 · FOZ
B.Braun Medical, Inc.
General Hospital · 170d
Cleared Aug 28, 2002
PRECISION PLUS TUNA OFFICE SYSTEM
K021804 · GEI
Medtronic Vascular
General & Plastic Surgery · 86d
Cleared Aug 28, 2002
SUTURE FIXATION DEVICE
K021834 · GAW
Mle, Inc.
General & Plastic Surgery · 85d