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
81937–81960 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 23, 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, BLUE COLOR
K001065 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 50d
Cleared May 23, 2000
PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH
K001122 · FTL
Ethicon, Inc.
General & Plastic Surgery · 46d
Cleared May 23, 2000
NITRILE EXAM GLOVES, POWDER-FREE, COLOR BLUE
K001128 · LZA
Shanghai Poseidon Plastic Products...
General Hospital · 46d
Cleared May 23, 2000
DISPOSABLE POWDERED NITRILE EXAM GLOVE, WHITE COLOR
K001155 · LZA
Sheen More Ent. Co., Ltd.
General Hospital · 43d
Cleared May 23, 2000
POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE CONTAINS 50 MICROGRAMS OR...
K001190 · LYY
Kossan Latex Industries(M)Sdn Bhd
General Hospital · 41d
Cleared May 23, 2000
CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
K001307 · JWH
Implex Corp.
Orthopedic · 29d
Cleared May 23, 2000
XIA SPINE SYSTEM HOOKS
K001319 · MNH
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared May 23, 2000
POWDERED LATEX EXAM GLOVES, PROTEIN LABELING (150 MICROGRAM OR LESS)
K001327 · LYY
Premier Pathway Sdn. Bhd.
General Hospital · 27d
Cleared May 23, 2000
EBI XFIX DFS METAPHYSEAL CORRECTION SYSTEM
K001358 · KTT
Ebi, L.P.
Orthopedic · 25d