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
82777–82800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Mar 03, 2000
IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5
K000012 · DLZ
Diagnostic Products Corp.
Toxicology · 60d
Cleared Mar 03, 2000
CELL-CHEX
K000076 · GJR
Streck Laboratories, Inc.
Hematology · 53d
Cleared Mar 03, 2000
CORTEK CYSTOSCOPE
K000197 · FAJ
Cortek Endoscopy, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 03, 2000
CORTEK URETHEROSCOPE
K000200 · FGB
Cortek Endoscopy, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 03, 2000
PROTEGE WHEELCHAIR
K000602 · IOR
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 9d
Cleared Mar 03, 2000
IO-DRIVE
K993081 · EGJ
Selectivemed Components, Inc.
Physical Medicine · 170d
Cleared Mar 03, 2000
AUTOSTAT II RHEUMATOID FACTOR IGA ELISA
K993557 · DHR
Cogent Diagnotics , Ltd.
Immunology · 135d
Cleared Mar 03, 2000
ENDOSCOPIC ANTI FOG DEVICE
K993604 · OCT
Mectra Labs, Inc.
Gastroenterology & Urology · 130d
Cleared Mar 03, 2000
DAKO MONOCLONAL MOUSE ANTI-HUMAN ESTROGEN RECEPTOR
K993957 · MYA
Dako Corp.
Pathology · 102d