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
76729–76752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 07, 2001
KIMAX REMOTE VIEWING STATION
K013098 · LLZ
Medical Metrics, Inc.
Radiology · 81d
Cleared Dec 07, 2001
VIATRONIC V3D CALCIUM SCORING
K013146 · JAK
Viatronix, Inc.
Radiology · 78d
Cleared Dec 07, 2001
COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD...
K013244 · FQM
Med Gen, Inc.
General Hospital · 70d
Cleared Dec 07, 2001
BI-3M NEEDLE-FREE INJECTOR SYSTEM
K013256 · KZE
Felton International, Inc.
General Hospital · 67d
Cleared Dec 07, 2001
LATEX EXAMINATION GLOVES POWDERFREE POLYMER COATED WITH PROTEIN CONCENT LABEL...
K013333 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 59d
Cleared Dec 07, 2001
ROYAL IMPERIAL POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K013537 · LYY
Koon Seng Sdn Bhd
General Hospital · 45d
Cleared Dec 07, 2001
KODAK DIRECTVIEW TABLETOP CASSETTE
K013686 · IXA
Eastman Kodak Company
Radiology · 30d
Cleared Dec 07, 2001
STERILE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CLAIM LESS THAN 50 UG/G
K013727 · KGO
Smart Glove Corp. Sdn Bhd
General Hospital · 28d
Cleared Dec 07, 2001
MAS LIPID CONTROL, LIQUID ASSAYED LIPID CONTROL, LEVEL 1 AND 2, DADE LIPID...
K013734 · JJY
Medical Analysis Systems, Inc.
Chemistry · 24d
Cleared Dec 07, 2001
CYBERMED, INC., V-WORKS
K013878 · LLZ
Cybermed, Inc.
Radiology · 14d
Cleared Dec 07, 2001
DAYLITE XENON LIGHT SOURCES
K013880 · GCT
Designs For Vision, Inc.
Gastroenterology & Urology · 14d
Cleared Dec 07, 2001
METAPAK MULTI-PURPOSE INSTRUMENT TRAY
K993535 · FRG
Riley Medical, Inc.
General Hospital · 780d
Cleared Dec 06, 2001
PLASMA SPRAYED SHOULDER
K003324 · KWS
Encore Orthopedics, Inc.
Orthopedic · 408d
Cleared Dec 06, 2001
COSMETICA (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
K011893 · LPL
Contact Color Srl
Ophthalmic · 171d
Cleared Dec 06, 2001
BAYER ADVIA IMS SYSTEM
K012337 · DCN
Bayer Corp.
Chemistry · 135d
Cleared Dec 06, 2001
REPROCESSED SOFT TISSUE ABLATORS
K012631 · GEI
Alliance Medical Corp.
General & Plastic Surgery · 115d
Cleared Dec 06, 2001
MEDIGROUP KEY TUBE
K013017 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 06, 2001
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123
K013027 · BTI
Respironics Healthscan, Inc.
Anesthesiology · 87d
Cleared Dec 06, 2001
PALOMAR SLP 1000
K013028 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 87d
Cleared Dec 06, 2001
FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM
K013047 · GEX
Mojca Valijavec
General & Plastic Surgery · 87d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9084
K013407 · DJG
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9079
K013408 · DJG
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9074
K013409 · MVO
Phamatech, Inc.
Toxicology · 52d
Cleared Dec 06, 2001
AT HOME DRUG TEST, MODEL 9064
K013410 · MVO
Phamatech, Inc.
Toxicology · 52d