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
89665–89688 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 17, 1998
IVAC MEDSYSTEM III, INFUSION PUMP W/DRUG EDITING SOFTWARE KIT
K961486 · MRZ
Ivac Medical Systems
General Hospital · 732d
Cleared Apr 17, 1998
SWARTZ DOPPLER FLOW PROBE AND MONITOR SYSTEM
K964001 · ITX
Med Institute, Inc.
Radiology · 557d
Cleared Apr 17, 1998
VIDAR VXR LS LASER FILM DIGITIZER
K974315 · LMA
Vidar Systems Corp.
Radiology · 151d
Cleared Apr 17, 1998
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS
K980199 · DZL
Synthes (Usa)
Dental · 87d
Cleared Apr 17, 1998
DUREX LATEX CONDOMS
K980204 · HIS
London Intl., LLC
Obstetrics & Gynecology · 87d
Cleared Apr 17, 1998
OLDELFT DIGIDELCA
K980296 · KPR
Oldelft Corp. of America
Radiology · 80d
Cleared Apr 17, 1998
PLANMECA DIXI, DIGITAL INTRAORAL X-RAY IMAGING SYSTEM
K980581 · EHD
Planmeca Oy
Radiology · 59d
Cleared Apr 17, 1998
IV DECANTER-FLEXIBLE
K980587 · LHI
Inrad
General Hospital · 59d
Cleared Apr 16, 1998
PTA BALLOON CATHETER
K972800 · LIT
Cook, Inc.
Cardiovascular · 262d
Cleared Apr 16, 1998
HARPOON SUTURE ANCHORS
K973775 · MBI
Biomet, Inc.
Orthopedic · 195d
Cleared Apr 16, 1998
MITEK BTB ABSORBABLE (PLA) CROSS PIN
K974341 · HTY
Mitek Products
Orthopedic · 149d
Cleared Apr 16, 1998
PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS
K974408 · LPL
Biocompatibles Eyewear, Inc.
Ophthalmic · 143d
Cleared Apr 16, 1998
MDA D-DIMER
K974776 · DAP
Organon Teknika Corp.
Hematology · 115d
Cleared Apr 16, 1998
STERICHEK PERACETIC ACID REAGENT STRIPS
K980164 · MSY
Environmental Test Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 16, 1998
PARTNERSHIP CALCAR FEMORAL COMPONENTS
K980239 · LZO
Howmedica, Inc.
Orthopedic · 83d
Cleared Apr 16, 1998
AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE
K980305 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 79d
Cleared Apr 16, 1998
MICROSTREAM FILLERLINE OR/EMS
K980324 · CCK
Oridion Medical , Ltd.
Anesthesiology · 78d
Cleared Apr 16, 1998
MICROSTREAM NASAL CANNULA FILTERLINE
K980325 · CCK
Oridion Medical , Ltd.
Anesthesiology · 78d
Cleared Apr 16, 1998
MICROSTREAM FILTERLINE ICU
K980327 · CCK
Oridion Medical , Ltd.
Anesthesiology · 78d
Cleared Apr 16, 1998
CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010
K980356 · HHT
Canadian Medical Brush, Inc.
Obstetrics & Gynecology · 77d
Cleared Apr 16, 1998
SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM
K980358 · KWP
Synthes (Usa)
Orthopedic · 77d
Cleared Apr 16, 1998
ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
K980363 · LBB
Orofacial Dynamics
Neurology · 77d
Cleared Apr 16, 1998
GLADRAGS COTTON MENSTRUAL PAD
K980395 · HHD
Keepers!, Inc.
Obstetrics & Gynecology · 73d
Cleared Apr 16, 1998
PRESS-FIT STEM
K980473 · LZO
Encore Orthopedics, Inc.
Orthopedic · 69d