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
81001–81024 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 2000
OBC-149 BREAST ARRAY COIL
K003340 · MOS
Mri Devices Corp.
Radiology · 14d
Cleared Nov 07, 2000
KM-10 TENS ELECTRODE
K000870 · GXY
Katecho, Inc.
Neurology · 232d
Cleared Nov 07, 2000
CNS-9300 SERIES CENTRAL STATION
K001433 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 183d
Cleared Nov 07, 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · DXZ
Ethicon, Inc.
Cardiovascular · 36d
Cleared Nov 07, 2000
MODIFICATION TO SPORICIDIN STERILIZING AND DISINFECTING SOLUTION
K003087 · MED
Sporicidin Intl.
General Hospital · 41d
Cleared Nov 07, 2000
MULTIPLE-VINYL EXAM GLOVE, POWDERED
K003133 · LYZ
Excellence Ent. Co., Ltd.
General Hospital · 32d
Cleared Nov 07, 2000
IMPLEX CONTINUUM HIP SYSTEM ACETABULAR COMPONENTS - MODEL XX-YYY-ZZZZ
K003181 · LPH
Implex Corp.
Orthopedic · 27d
Cleared Nov 07, 2000
DUPLOGRIP
K003193 · FMF
Baxter Healthcare Corp
General Hospital · 26d
Cleared Nov 07, 2000
BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT
K003204 · GNW
Intracel Corp.
Microbiology · 25d
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