FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
128305–128328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1990
TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE
K896439 · BZO
Ventlab Corp.
Anesthesiology · 61d
Cleared Jan 09, 1990
RATE INCREASE FOR IPPB/IPV
K896586 · DZD
Percussionaire Corp.
Dental · 48d
Cleared Jan 09, 1990
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE
K896595 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Jan 09, 1990
S.A.F. ACETABULAR CUP WITH POROUS COATING
K896614 · JDL
Synergy Orthopaedics Intl., Inc.
Orthopedic · 49d
Cleared Jan 09, 1990
LISTING ENT AS INTENDED USE FOR ENDOGUIDE
K896617 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Jan 09, 1990
LIST GENERAL SURGERY AS INTENDED USE FOR ENDOGUIDE
K896618 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Jan 09, 1990
LIST DERMATOLOGY/PLASTIC SURGERY AS USE ENDOGUIDE
K896619 · GEX
Luxar Corp.
General & Plastic Surgery · 49d
Cleared Jan 09, 1990
LISTING PODIATRY AS INTENDED USE FOR ENDOGUIDE
K896711 · GEX
Luxar Corp.
General & Plastic Surgery · 42d
Cleared Jan 09, 1990
CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.
K896724 · GEH
Stiefel Research Institute, Inc.
General & Plastic Surgery · 41d
Cleared Jan 08, 1990
MODEL DS-3300 DYNASCOPE PATIENT MONITOR
K894628 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 168d
Cleared Jan 08, 1990
MULES SPHERE GLASS (SEVERAL SIZES)
K895908 · HPZ
Ginsberg Scientific, Inc.
Ophthalmic · 90d
Cleared Jan 08, 1990
INAMED CLOSED-WOUND DRAIN SYSTEM
K896491 · GCY
Inamed Development Co.
General & Plastic Surgery · 56d
Cleared Jan 08, 1990
MENSTRUAL TAMPON
K897008 · HEB
Personal Products Co.
Obstetrics & Gynecology · 19d
Cleared Jan 05, 1990
MODEL 500A VASCULAR SPECTRUM ANALYZER W/DOPPLER
K881263 · HGL
Multigon Industries, Inc.
Obstetrics & Gynecology · 652d
Cleared Jan 05, 1990
MENNEN BONE FIXATION DEVICE
K892411 · JDQ
Dentsply Intl.
Orthopedic · 273d
Cleared Jan 05, 1990
WHITESIDE ORTHOLOC MODULAR-C TOTAL KNEE SYSTEM
K896045 · JWH
Dow Corning Wright
Orthopedic · 80d
Cleared Jan 04, 1990
LUQUE III SPINAL SYSTEM AND LUQUE MINI-SET
K890192 · KWP
Danek Medical, Inc.
Orthopedic · 351d
Cleared Jan 04, 1990
ITC PRESCRIPTION SERIES MODEL CA AND C
K891914 · ESD
Us Hearing Centers, Inc.
Ear, Nose, Throat · 283d
Cleared Jan 04, 1990
BIO-STYM 250 (MUSCLE STIMULATOR)
K891987 · IPF
Electronic Health Technologies, Inc.
Physical Medicine · 282d
Cleared Jan 04, 1990
DISPOSABLE NEEDLE, ASPIRATION AND INJECTION
K893233 · FMF
Pioneer Intl. Co.
General Hospital · 251d
Cleared Jan 04, 1990
MODEL 5070
K894855 · LNH
Medical Advances, Inc.
Radiology · 157d
Cleared Jan 04, 1990
K-2 TENS OR MED TENS
K894964 · GZJ
Oms Medical Supplies, Inc.
Neurology · 139d
Cleared Jan 04, 1990
INTRAMEDULLARY HIP SCREW
K895241 · KTT
Richards Medical Co., Inc.
Orthopedic · 136d
Cleared Jan 04, 1990
AURAL-TECH ITE HEARING AID MODEL AT-1S, 1SA, 1SC
K895517 · ESD
Aural Technologies, Inc.
Ear, Nose, Throat · 114d