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
87745–87768 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1998
SILVERSTREAK HYDROPHILIC GUIDEWIRE
K982543 · DQX
Micro Therapeutics, Inc.
Cardiovascular · 143d
Cleared Dec 11, 1998
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
K982651 · HEL
Corometrics Medical Systems, Inc.
Obstetrics & Gynecology · 134d
Cleared Dec 11, 1998
CDR - PAN MODEL 4700
K982661 · MQB
Schick Technologies, Inc.
Radiology · 134d
Cleared Dec 11, 1998
INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
K983200 · GAA
Ximed/Prosure/Injectx
General & Plastic Surgery · 88d
Cleared Dec 11, 1998
POWER BLOCK
K983227 · EIE
Kreativ, Inc.
Dental · 87d
Cleared Dec 11, 1998
SIRONA C8 DENTAL OPERATIVE UNIT WITH ACCESSORIES
K983242 · EIA
Sirona Dental Systems GmbH
Dental · 86d
Cleared Dec 11, 1998
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY
K983313 · IZH
Elscint, Inc.
Radiology · 81d
Cleared Dec 11, 1998
ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
K983320 · HIS
Suretex Prophylactics (India) , Ltd.
Obstetrics & Gynecology · 81d
Cleared Dec 11, 1998
DYNAREX TRACHEOSTOMY SPONGE
K983348 · EFQ
Dynarex Corp.
General & Plastic Surgery · 79d
Cleared Dec 11, 1998
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983350 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 79d
Cleared Dec 11, 1998
ILO292 DP ECHOPORT PLUS OAE SYSTEM
K983351 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 79d
Cleared Dec 11, 1998
ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
K983352 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 79d
Cleared Dec 11, 1998
OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM
K983382 · MEH
Osteonics Corp.
Orthopedic · 77d
Cleared Dec 11, 1998
SURECAUT DIAMOND LASER KNIFE
K983463 · GEX
Clinicon Corp.
General & Plastic Surgery · 71d
Cleared Dec 11, 1998
VERTICAL LIFT
K983526 · ING
Barnes,Richardson & Colburn
Physical Medicine · 64d
Cleared Dec 11, 1998
SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT
K983599 · HHT
Andwin Scientific
Microbiology · 58d
Cleared Dec 11, 1998
XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011
K983628 · GCT
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 57d
Cleared Dec 11, 1998
SEARE BIOMEDICAL SILICONE RODS
K983630 · MIB
Seare Biomedical Corp.
General & Plastic Surgery · 57d
Cleared Dec 11, 1998
MAX-ACT
K983649 · JBP
Array Medical, Inc.
Hematology · 56d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
K983697 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
K983699 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
K983700 · JXN
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
K983701 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 51d
Cleared Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
K983703 · DJR
Roche Diagnostic Systems, Inc.
Toxicology · 51d