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
80497–80520 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 2000
R & D 3K RETIC
K003208 · JPK
R&D Systems, Inc.
Hematology · 25d
Cleared Nov 06, 2000
FRIENDLY LIGHT ER:YAG PULSED LASER
K000023 · GEX
Innotech USA, Inc.
General & Plastic Surgery · 307d
Cleared Nov 06, 2000
WILLI GELLER CREATION AND LF PORCELAIN
K002904 · EIH
Jensen Industries, Inc.
Dental · 49d
Cleared Nov 06, 2000
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000
K002990 · HBL
Vascular Technology Incorporated
Neurology · 42d
Cleared Nov 06, 2000
PE.R.I. II KNEE FRACTURE SYSTEM
K003235 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 20d
Cleared Nov 06, 2000
MODEL K7 EVALUATION DEVICE
K003287 · KZM
Myotronics-Noromed, Inc.
Dental · 17d
Cleared Nov 06, 2000
BIOMET SCK KNEE SYSTEM
K003296 · JWH
Biomet, Inc.
Orthopedic · 17d
Cleared Nov 06, 2000
VIPON TAMPON
K992493 · HEB
Another Way Products, LLC
Obstetrics & Gynecology · 469d
Cleared Nov 03, 2000
ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM
K001044 · MNH
Acme Spine, LLC
Orthopedic · 217d
Cleared Nov 03, 2000
CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40,...
K001213 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 203d
Cleared Nov 03, 2000
MERIDIAN-II AND MERDIAN-PLUS
K001347 · GZO
Meridian Co., Ltd.
Neurology · 189d
Cleared Nov 03, 2000
MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149
K001714 · NHK
Mercury Medical
Anesthesiology · 151d
Cleared Nov 03, 2000
ESTATION ELECTRONIC STETHOSCOPE, MODEL DR200
K001788 · DQD
Erecords Enterprises
Cardiovascular · 143d
Cleared Nov 03, 2000
ENDOPATH ETS45, ETS FLEX45, ETS COMPACT-FLEX45 LINEAR CUTTERS, ETS FLEX45 AND...
K002398 · OCW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 03, 2000
CANDELA MID IR DIODE LASER SYSTEM
K002421 · GEX
Candela Corp.
General & Plastic Surgery · 87d
Cleared Nov 03, 2000
NOVALIS (SHAPED BEAM SURGERY SYSTEM)
K002509 · MUJ
Brainlab AG
Radiology · 80d
Cleared Nov 03, 2000
PILLING E-FRAZIER BIPOLAR SUCTION TUBE
K002582 · GEI
Pilling
General & Plastic Surgery · 77d
Cleared Nov 03, 2000
KSEA MINIATURE NEUROENDOSCOPE
K002704 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 65d
Cleared Nov 03, 2000
3D ENDOSCOPE
K002924 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 45d
Cleared Nov 03, 2000
PROFEEL POWDER FREE POLYMER COATED NEOPRENE SURGICAL GLOVES STERILE
K003019 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 37d
Cleared Nov 03, 2000
HERMES PORT EXPANDER
K003217 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 21d
Cleared Nov 03, 2000
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K003222 · GCI
Computer Motion, Inc.
General & Plastic Surgery · 18d
Cleared Nov 03, 2000
RS NITRILSTST MEDICAL EXAMINATION GLOVES, POWDERED (NON STERILE) BLUE
K003233 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 17d
Cleared Nov 03, 2000
BIOMET LATERAL TROCH PLATE
K003294 · JDW
Biomet, Inc.
Orthopedic · 14d