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
86065–86088 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1999
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
K991797 · JHX
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jun 08, 1999
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN...
K983511 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 244d
Cleared Jun 08, 1999
RPM RESPIRATORY GATING SYSTEM
K983629 · LHN
Varian Medical Systems, Inc.
Radiology · 236d
Cleared Jun 08, 1999
PRODIMED MICROINJECTION PIPETTES
K983713 · MQH
Prodimed
Obstetrics & Gynecology · 230d
Cleared Jun 08, 1999
AMIGO MODEL 590000
K983987 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 211d
Cleared Jun 08, 1999
VIVOSONIC
K984562 · ITX
Sonotech, Inc.
Radiology · 167d
Cleared Jun 08, 1999
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER
K990795 · MTD
Cardiac Pathways Corp.
Cardiovascular · 90d
Cleared Jun 08, 1999
MINIMED 508 INSULIN PUMP
K990801 · LZG
Medtronic Minimed
General Hospital · 90d
Cleared Jun 08, 1999
DOSE CALC, MODEL VS. 1.02
K990833 · IYE
Integrity Medical Software, Inc.
Radiology · 88d
Cleared Jun 08, 1999
HOC SET WITH VALVE, HOC SET WITHOUT VALVE, HOC SET WITH VALVE - SOFT PLUG,...
K990913 · MQE
Laboratoires Prodimed
Obstetrics & Gynecology · 82d
Cleared Jun 08, 1999
LINEAR SHOULDER COIL, MODEL 414GE-09
K991115 · MOS
Medical Advances, Inc.
Radiology · 68d
Cleared Jun 08, 1999
VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES, CLEAR AND...
K991163 · LPL
Vistakon, Johnson & Johnson Vision...
Ophthalmic · 62d
Cleared Jun 08, 1999
DISTENDER SERIES II BAROSTAT
K991288 · FFX
G & J Electronics, Inc.
Gastroenterology & Urology · 55d
Cleared Jun 08, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION
K991553 · JAK
Shimadzu Corp.
Radiology · 36d
Cleared Jun 08, 1999
IDS4 V3.2 IMAGE DISPLAY SYSTEM
K991643 · LLZ
O Tech, Inc.
Radiology · 26d
Cleared Jun 07, 1999
MEDIPOINT
K982961 · GZJ
Medipoint , Ltd.
Neurology · 287d
Cleared Jun 07, 1999
COOLTOUCH V ND:YAG
K983984 · GEX
Laser Aesthetics, Inc.
General & Plastic Surgery · 210d
Cleared Jun 07, 1999
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
K990814 · GJT
Precision Biologic
Hematology · 88d
Cleared Jun 07, 1999
LEICA AT550
K990869 · HKX
Leica Microsystems, Inc.
Ophthalmic · 83d
Cleared Jun 07, 1999
MASIMO SET 2000 PULSE OXIMETER, MASIMO LNOP -ADT-ADULT/PEDIATRIC DISPOSABLE...
K990966 · DQA
Masimo Corp.
Anesthesiology · 76d
Cleared Jun 07, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA...
K991773 · DSI
Hewlett-Packard GmbH
Cardiovascular · 13d
Cleared Jun 04, 1999
GASTRIC AND RECTAL CATHETERS
K973844 · FFX
G & J Electronics, Inc.
Gastroenterology & Urology · 604d
Cleared Jun 04, 1999
STRYKER INFRAVISION ESOPHAGEAL KIT
K983220 · FAT
Stryker Endoscopy
Gastroenterology & Urology · 263d
Cleared Jun 04, 1999
AUTO SUTURE ABBI SYSTEM
K983296 · KNW
United States Surgical, A Division of...
Gastroenterology & Urology · 256d