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
82441–82464 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 2000
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
K000645 · DPS
General Electric Medical Systems...
Cardiovascular · 89d
Cleared May 24, 2000
PROTON VISION
K000922 · MUJ
Varian Assoc., Inc.
Radiology · 63d
Cleared May 24, 2000
ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
K000958 · CDQ
Elan Holdings, Inc.
Chemistry · 61d
Cleared May 24, 2000
WAKO LIPASE CALIBRATOR
K001002 · JIS
Wako Chemicals USA, Inc.
Chemistry · 56d
Cleared May 24, 2000
DORNIER MEDILAS H
K001243 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 36d
Cleared May 24, 2000
CONTROL PLASMA N
K001256 · GIZ
Dade Behring, Inc.
Hematology · 35d
Cleared May 24, 2000
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
K001346 · DYB
St. Jude Medical, Inc.
Cardiovascular · 26d
Cleared May 24, 2000
BIOSCANNER TRIGLYCERIDES TEST STRIPS
K991894 · JGY
Polymer Technology Systems, Inc.
Chemistry · 356d
Cleared May 24, 2000
HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO....
K993355 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 231d
Cleared May 23, 2000
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL...
K000108 · EMX
Bhk Holding
Ear, Nose, Throat · 130d
Cleared May 23, 2000
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
K000178 · KGO
Terang Nusa Sdn Bhd
General Hospital · 124d
Cleared May 23, 2000
NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT
K000604 · IMI
Naturopathic Laboratories...
Physical Medicine · 90d
Cleared May 23, 2000
CARDTEL, MODEL NT-100
K000609 · MWJ
Cardiac Telecommunications
Cardiovascular · 90d
Cleared May 23, 2000
SCANDINAVIAN IVF SCIENCES AB, G1.2
K000625 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 96d
Cleared May 23, 2000
SCANDINAVIAN IVF SCIENCES AB, GAMETE-100
K000626 · MQL
Vitrolife AB/Scandinavian Ivf...
Obstetrics & Gynecology · 96d
Cleared May 23, 2000
REACH FEMORAL COMPONENT
K000760 · LPH
Biomet, Inc.
Orthopedic · 76d
Cleared May 23, 2000
HOFFMANN II EXTERNAL FIXATION SYSTEM
K000957 · LXT
Howmedica Osteonics Corp.
Orthopedic · 60d
Cleared May 23, 2000
FOWLER ENDOCURETTE, MODEL CUR-XXX
K000974 · HHK
Utah Medical Products, Inc.
Obstetrics & Gynecology · 57d
Cleared May 23, 2000
PASS SPINAL SYSTEM
K001024 · MNH
Encore Orthopedics, Inc.
Orthopedic · 54d
Cleared May 23, 2000
GEIGER NEEDLE ADAPTER, MODEL 406
K001029 · GEI
Geiger Medical Technologies, Inc.
General & Plastic Surgery · 54d
Cleared May 23, 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
K001035 · JWY
Trek Diagnostic Systems, Inc.
Microbiology · 53d
Cleared May 23, 2000
AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FOR AGC-SPEED,...
K001041 · EJT
Wieland Edelmetalle GmbH & Co.
Dental · 53d
Cleared May 23, 2000
COMFORT LATEX POWDERED PATIENT EXAMINATION GLOVES WITH PROTEIN LABEL CLAIM...
K001042 · LYY
Comfort Rubber Gloves Industries Sdn....
General Hospital · 53d
Cleared May 23, 2000
GUTHRIE POWDER-FREE LATEX SURGICAL GLOVE WITH (50 MICROGRAMS OR LESS)
K001049 · KGO
Guthrie Medicare Products (Melaka)...
General Hospital · 53d