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
86881–86904 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1999
CCS
K983105 · EJI
Dentsply Midwest
Dental · 185d
Cleared Mar 08, 1999
FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS
K983126 · FIP
Minntech Corp.
Gastroenterology & Urology · 181d
Cleared Mar 08, 1999
ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATING
K984394 · DQX
Guidant Corp.
Cardiovascular · 90d
Cleared Mar 08, 1999
RF
K990035 · DHR
Abbott Laboratories
Immunology · 61d
Cleared Mar 08, 1999
OPTIBOND SOLO PLUS
K990498 · KLE
Sybron Dental Specialties, Inc.
Dental · 19d
Cleared Mar 05, 1999
BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT
K980351 · LSR
Boston Biomedica, Inc.
Microbiology · 400d
Cleared Mar 05, 1999
AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MODEL NUMBER WS-300
K981702 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 295d
Cleared Mar 05, 1999
IMFAST
K982952 · LHN
Siemens Medical Solutions USA, Inc.
Radiology · 193d
Cleared Mar 05, 1999
RESTORE (AKA RE/STOR)
K983164 · MNG
Nebl, Inc.
Gastroenterology & Urology · 176d
Cleared Mar 05, 1999
SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS)
K983194 · MED
Sporicidin Intl.
General Hospital · 175d
Cleared Mar 05, 1999
ACCU GUIDE
K984382 · IYO
Tayman Medical, Inc.
Radiology · 87d
Cleared Mar 05, 1999
AURA DYE LASER SYSTEM (ADLS)
K984424 · GEX
Laserscope
General & Plastic Surgery · 84d
Cleared Mar 05, 1999
ORBSCAN
K984443 · MXK
Technolas Perfect Vision GmbH
Ophthalmic · 81d
Cleared Mar 05, 1999
COOL-TIP RF SYSTEM
K984552 · GEI
Radionics, Inc.
General & Plastic Surgery · 73d
Cleared Mar 05, 1999
SYNTEC-TAICHUNG NON-STERILE UNREAMED INTERLOCKING NAIL SYSTEM
K984602 · HSB
Syntec Scientific Corp.
Orthopedic · 67d
Cleared Mar 05, 1999
PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC...
K984607 · FBP
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 67d
Cleared Mar 05, 1999
MAXIM REMOVABLE MOLDED POLY TIBIA
K984623 · JWH
Biomet, Inc.
Orthopedic · 65d
Cleared Mar 05, 1999
MULTITAK SS BUTTONS
K990156 · MBI
Bonutti Research
Orthopedic · 45d
Cleared Mar 05, 1999
BONE ANCHOR SYSTEM III (BAS III)
K990295 · MBI
Boston Scientific Corp
Orthopedic · 35d
Cleared Mar 05, 1999
EXMOOR SUCTION CLEARANCE KIT
K990366 · LRC
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 28d
Cleared Mar 04, 1999
EBV-VCA IGG ELISA TEST SYSTEM
K981812 · LSE
Diamedix Corp.
Microbiology · 286d
Cleared Mar 04, 1999
LIGHTSHEER LONG PULSE RUBY LASER
K982980 · GEX
Palomar Medical Products, Inc.
General & Plastic Surgery · 190d
Cleared Mar 04, 1999
POLYMER OBL SB ANCHOR / SUTURE COMBINATION
K982996 · JDR
Orthopaedic Biosystems, Ltd.
Orthopedic · 189d
Cleared Mar 04, 1999
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071 · MQM
Respironics, Inc.
Chemistry · 183d