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
102529–102552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1995
MANDIBULAR BONE DISTRACTOR
K945674 · MQN
Howmedica Corp.
Dental · 196d
Cleared Jun 02, 1995
NEUROSIGN 100 IMPEDANCE METER
K945799 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 186d
Cleared Jun 02, 1995
NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER
K945909 · KRA
Navarre Biomedical , Ltd.
Cardiovascular · 182d
Cleared Jun 02, 1995
STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM
K950114 · HQC
Storz Instrument Co.
Ophthalmic · 142d
Cleared Jun 02, 1995
IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS
K950340 · MMK
Bemis Mfg. Co.
General Hospital · 126d
Cleared Jun 02, 1995
POWDER FREE LATEX EXAMINATION GLOVES
K950450 · LYY
Rampart Glove Co.
General Hospital · 119d
Cleared Jun 02, 1995
MEGA MEDITEX LIMITED
K950622 · LYY
Mega Meditex , Ltd.
General Hospital · 112d
Cleared Jun 02, 1995
DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE
K950956 · GXQ
Bio-Vascular, Inc.
Neurology · 92d
Cleared Jun 02, 1995
MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM
K950957 · CBF
Gulf Coast Hyperbarics, Inc.
Anesthesiology · 92d
Cleared Jun 02, 1995
STRATO/INFUSAID TUNNELER
K950987 · LJS
Strato/Infusaid, Inc.
General Hospital · 91d
Cleared Jun 02, 1995
BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH
K950993 · EFW
John O. Butler
Dental · 91d
Cleared Jun 02, 1995
DAVOL ARTHRO-FLO 3
K951026 · HRX
Davol Inc., Sub. C. R. Bard, Inc.
Orthopedic · 88d
Cleared Jun 02, 1995
BACTERIAL/VIRAL FILTER PRODUCT NUMBERS 5100FILT, 5100THINM, 5100HEPA
K951047 · CAH
Vital Signs, Inc.
General Hospital · 88d
Cleared Jun 02, 1995
HDC VADD (VASCULAR ACCESS DEVICE) TUNNELER
K951098 · LJS
Hdc Corp.
General Hospital · 85d
Cleared Jun 02, 1995
LIFEFORCE CLINICAL HYPERBARIC FACILITY
K951125 · CBF
Reimers Systems, Inc.
Anesthesiology · 81d
Cleared Jun 02, 1995
PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
K951292 · KYB
Chiron Vision Corp.
Ophthalmic · 72d
Cleared Jun 02, 1995
RIONET HEARING AID HM-02
K951677 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 52d
Cleared Jun 02, 1995
DEGULOR M
K951779 · EJT
Degussa Corp.
Dental · 49d
Cleared Jun 02, 1995
PORS ON PLUS
K951781 · EJT
Degussa Corp.
Dental · 49d
Cleared Jun 02, 1995
BOND-ON 4
K951783 · EJT
Degussa Corp.
Dental · 46d
Cleared Jun 02, 1995
OSTEOTOMES
K952193 · DZE
Steri-Oss, Inc.
Dental · 24d
Cleared Jun 01, 1995
STAPHAUREX PLUS(TM)
K945538 · JWX
Murex Diagnostics Limitd
Microbiology · 199d
Cleared Jun 01, 1995
MODEL 550-DC CROSSFIRE(TM)
K945564 · GEX
Eclipse, Inc.
General & Plastic Surgery · 217d
Cleared Jun 01, 1995
ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES
K950592 · HRX
Eare Consulting Service
Orthopedic · 112d