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
88177–88200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1998
UBI MAGIWEL PAP (PROSTATIC ACID PHOSPHATASE) EIA QUANTITATVE
K981573 · JFH
United Biotech, Inc.
Chemistry · 134d
Cleared Sep 15, 1998
HEMAPROMPT
K981661 · KHE
Aerscher Diagnostics
Hematology · 132d
Cleared Sep 15, 1998
VARIOUS DENTAL IMPLANTS
K982111 · DZE
Biotech Medical Instruments Corp.
Dental · 91d
Cleared Sep 15, 1998
OSCILLOMATE EMS NIBP MONITOR MODEL 9001
K982135 · DXN
Cas Medical Systems, Inc.
Cardiovascular · 90d
Cleared Sep 15, 1998
BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM
K982139 · JEY
Bionx Implants, Inc.
Dental · 90d
Cleared Sep 15, 1998
SPECTRUM 800 CURING UNIT
K982318 · EBF
Dentsply Intl.
Dental · 75d
Cleared Sep 15, 1998
ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48,...
K982343 · DHB
Pharmacia & Upjohn Co.
Immunology · 71d
Cleared Sep 15, 1998
PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.
K982480 · EIA
Dentalview, Inc.
Dental · 61d
Cleared Sep 15, 1998
HDLC PRECIPITATING REAGENT
K982539 · LBS
Ac Biochemicals, Inc.
Chemistry · 56d
Cleared Sep 15, 1998
RENEW
K982729 · EBF
Bisco, Inc.
Dental · 41d
Cleared Sep 14, 1998
UB ANALYZER UA-2, REAGENT KIT AND BILIRUBIN CONTROL
K972382 · CIG
Arrows Co., Ltd.
Chemistry · 445d
Cleared Sep 14, 1998
VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER
K980566 · FOZ
Boston Scientific Corp
General Hospital · 213d
Cleared Sep 14, 1998
LICHEN, BACTERIAL IN LINE BREATHING FILTER
K980662 · CAH
Dhd Healthcare Corp.
General Hospital · 206d
Cleared Sep 14, 1998
DILKES LASER/SUCTION CANNULAE
K981143 · GEX
Exmoor Plastics , Ltd.
General & Plastic Surgery · 168d
Cleared Sep 14, 1998
AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200...
K981570 · GEI
Aaron Medical Industries
General & Plastic Surgery · 133d
Cleared Sep 14, 1998
PICTOOLS MEDICAL TOOL KIT MODEL 1.0
K982146 · LLZ
Pegasus Imaging Corp.
Radiology · 89d
Cleared Sep 14, 1998
SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
K982169 · MBI
Doctor'S Research Group, Inc.
Orthopedic · 87d
Cleared Sep 14, 1998
CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
K982191 · EBF
Medental Intl.
Dental · 84d
Cleared Sep 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982320 · KWP
Depuy, Inc.
Orthopedic · 74d
Cleared Sep 14, 1998
SURGI STIM
K982388 · IPF
Vision Quest Industries, Inc.
Physical Medicine · 67d
Cleared Sep 14, 1998
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
K982390 · KTW
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Sep 14, 1998
VISIVOX, MODEL V-2
K982396 · LEZ
Rsq, LLC
Ear, Nose, Throat · 67d
Cleared Sep 14, 1998
AEROTEE, MODEL # 1001
K982408 · CAF
Piper Medical Products
Anesthesiology · 66d
Cleared Sep 14, 1998
FIBER OPTIC ENDOILLUMINATION PROBE
K982462 · FFS
Microvision, Inc.
Gastroenterology & Urology · 61d