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
87577–87600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 16, 1998
NAPA EIA ASSAY
K983812 · LAN
Diagnostic Reagents, Inc.
Toxicology · 19d
Cleared Nov 16, 1998
ABBOTT AXSYM MYOGLOBIN
K983848 · DDR
Abbott Laboratories
Chemistry · 17d
Cleared Nov 16, 1998
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL...
K983980 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 7d
Cleared Nov 13, 1998
DISPOSABLE CANNULA TRACHEOSTOMY TUBE, WITH INNER CANNULA
K970811 · JOH
Pneumocare, Inc.
Anesthesiology · 618d
Cleared Nov 13, 1998
NIR BILIARY STENT
K973171 · FGE
Medinol, Ltd.
Gastroenterology & Urology · 445d
Cleared Nov 13, 1998
MEDI-TRACE 4103 NEONATAL ELECTRODE
K981964 · DRX
Graphic Controls Corp.
Cardiovascular · 162d
Cleared Nov 13, 1998
HEARTLINK, MODEL II
K982803 · QYX
Cardiac Telecom Corp.
Cardiovascular · 95d
Cleared Nov 13, 1998
METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES...
K983021 · LPL
Metrosoft, Inc.
Ophthalmic · 74d
Cleared Nov 13, 1998
FRACTURE RISK OPTION FOR THE QDR BONE DENSITOMETER, MODEL#S QDR4500, QDR2000,...
K983028 · KGI
Hologic, Inc.
Radiology · 74d
Cleared Nov 13, 1998
HEMOCOR HPH 700 HEMOCONCENTRATOR
K983085 · KDI
Minntech Corp.
Gastroenterology & Urology · 71d
Cleared Nov 13, 1998
BLOWER/MISTER
K983135 · FQH
Cardiothoracic Systems, Inc.
General Hospital · 66d
Cleared Nov 13, 1998
MUCOPREN SOFT RELINING SYSTEM
K983357 · EBI
Roydent Dental Products, Inc.
Dental · 50d
Cleared Nov 13, 1998
PANAVIA F
K983361 · EMA
Kuraray America, Inc.
Dental · 50d
Cleared Nov 13, 1998
CARDIOBEEPER CB250
K983582 · DXH
Merdian Medical Technologies , Ltd.
Cardiovascular · 31d
Cleared Nov 13, 1998
STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND...
K983786 · DZE
Sterngold/Implamed
Dental · 17d
Cleared Nov 12, 1998
SCIMED INFORMER PRESSURE WIRE SYSTEM
K974241 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 365d
Cleared Nov 12, 1998
HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K980711 · LPH
Zimmer, Inc.
Orthopedic · 261d
Cleared Nov 12, 1998
ESPRIT VENTILATOR
K981072 · CBK
Respironics, Inc.
Anesthesiology · 233d
Cleared Nov 12, 1998
SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID...
K981885 · INI
Sunrise Medical, Inc.
Physical Medicine · 167d
Cleared Nov 12, 1998
PROFA
K981911 · IYE
Duncan Hynd Associates, Ltd.
Radiology · 164d
Cleared Nov 12, 1998
AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
K982831 · JXM
OraSure Technologies, Inc.
Toxicology · 93d
Cleared Nov 12, 1998
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
K982906 · MQN
Walter Lorenz Surgical, Inc.
Dental · 86d
Cleared Nov 12, 1998
BOEHRINGER MANNHEIM TINA-QUANT IGE TEST
K983185 · DGC
Boehringer Mannheim Corp.
Immunology · 62d
Cleared Nov 12, 1998
DIGOXIN IMMUNOASSAY
K983323 · KXT
Diagnostic Reagents, Inc.
Toxicology · 51d