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
90169–90192 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1998
LASERLITE DIODE SURGICAL LASER
K981090 · GEX
Laserlite, LLC
General & Plastic Surgery · 26d
Cleared Apr 21, 1998
SYSTEM 7500 ABC ELECTROSURGICAL UNIT
K981220 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 18d
Cleared Apr 21, 1998
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
K981339 · JJY
Consolidated Technologies, Inc.
Chemistry · 8d
Cleared Apr 20, 1998
JTECH COMMANDER AND ALGOMETER
K971407 · HRW
J-Tech Medical, Inc.
Neurology · 369d
Cleared Apr 20, 1998
HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
K971504 · DRF
J-Lloyd Medical, Inc.
Cardiovascular · 360d
Cleared Apr 20, 1998
ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
K973639 · DRF
J-Lloyd Medical, Inc.
Cardiovascular · 208d
Cleared Apr 20, 1998
INFUTEST 2000 INFUSION DEVICE ANALYZER
K980165 · MRZ
Datrend Systems, Inc.
General Hospital · 94d
Cleared Apr 20, 1998
AHMED GLAUCOMA VALVE, MODEL S3
K980657 · KYF
New World Medical, Inc.
Ophthalmic · 74d
Cleared Apr 20, 1998
POWER COINS GLOW IN THE DARK LIGATURES
K980864 · ECI
Ortho Kinetics Corp.
Dental · 46d
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