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
83281–83304 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 07, 2000
STARION CAUTERY HOOK
K000296 · GEI
Starion Instruments
General & Plastic Surgery · 36d
Cleared Mar 07, 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K000397 · FHN
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Mar 07, 2000
ISOBAR SPINAL SYSTEM
K000425 · MNI
Encore Orthopedics, Inc.
Orthopedic · 27d
Cleared Mar 07, 2000
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI...
K000447 · LAF
Phamatech
Toxicology · 26d
Cleared Mar 07, 2000
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K000513 · KWQ
Ebi, L.P.
Orthopedic · 20d
Cleared Mar 07, 2000
SUCTION VASCULAR STAPLER AND IMPLANTABLE STAPLE SYSTEM
K000608 · GDW
Std Mfg., Inc.
General & Plastic Surgery · 13d
Cleared Mar 07, 2000
MEDI-CULT ACIDIFIED TYRODES SOLUTION- MEDIUM
K991470 · MQL
Medicult A/S
Obstetrics & Gynecology · 328d
Cleared Mar 07, 2000
ALLON 2000
K992386 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 235d
Cleared Mar 07, 2000
SAS STREP A TEST
K993456 · GTY
Sa Scientific, Inc.
Microbiology · 146d
Cleared Mar 07, 2000
MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2
K993584 · BZD
Nellcor Puritan Bennett France Dvpt.
Anesthesiology · 137d
Cleared Mar 07, 2000
CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA...
K994167 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 89d
Cleared Mar 07, 2000
AIRIS II
K994378 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 71d
Cleared Mar 07, 2000
E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE
K994428 · GEI
Valleylab, Inc.
General & Plastic Surgery · 68d
Cleared Mar 06, 2000
FREQUENCY 55, FREQUENCY 55 ASPHERIC, ENCORE, ENCORE TORIC, ONEVIEW, COOPERFLEX
K000384 · LPL
CooperVision, Inc.
Ophthalmic · 28d
Cleared Mar 06, 2000
MODIFICATION TO AUTOJECT MINI
K000482 · KZH
Owen Mumford, Ltd.
General Hospital · 21d
Cleared Mar 06, 2000
ACME MEDICAL AESTHETIC ND:YAG LASER
K991798 · GEX
Altus Medical
General & Plastic Surgery · 285d
Cleared Mar 06, 2000
Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)
K992908 · DSI
Quinton, Inc.
Cardiovascular · 189d
Cleared Mar 06, 2000
SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
K994128 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Mar 06, 2000
GRASS TS3201/6401 EEG AMPLIFIER SYSTEM
K994142 · OLV
Grass Instrument Co.
Neurology · 89d
Cleared Mar 06, 2000
THE LIGAMENT ANCHOR SOFT SCREW
K994152 · HWC
Corin USA
Orthopedic · 89d
Cleared Mar 06, 2000
ART-M3 25K, MODEL M3-1-ART2-A1
K994203 · ELC
Bonart Co., Ltd.
Dental · 84d
Cleared Mar 06, 2000
ART-P3, MODEL P3-1-ART-A1
K994299 · ELC
Bonart Co., Ltd.
Dental · 76d
Cleared Mar 06, 2000
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
K994363 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 70d
Cleared Mar 03, 2000
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 &...
K000005 · LEG
Diagnostic Products Corp.
Toxicology · 60d