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
85561–85584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 04, 1999
RC CORNET, MODEL #44F50
K983308 · BWF
Pari Holding Co.
Anesthesiology · 256d
Cleared Jun 04, 1999
SURGISORB
K984374 · GAM
Samyang Corp.
General & Plastic Surgery · 179d
Cleared Jun 04, 1999
SUGITA TITANIUM ANEURYSM CLIP
K990202 · HCH
Mizuho America, Inc.
Neurology · 134d
Cleared Jun 04, 1999
SOLO ORTHO
K990743 · DYH
Sybron Dental Specialties, Inc.
Dental · 88d
Cleared Jun 04, 1999
MODIFICATION TO WOUN'DRES
K991202 · MGQ
Coloplast Corp.
General & Plastic Surgery · 74d
Cleared Jun 04, 1999
COPALIS MULTIPLEX EBV ANTIBODY ASSAY
K991660 · LSE
DiaSorin, Inc.
Microbiology · 21d
Cleared Jun 03, 1999
A P HARNESS
K981860 · KMK
Paraworks Enterprise, Ltd.
General Hospital · 372d
Cleared Jun 03, 1999
SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
K983996 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 205d
Cleared Jun 03, 1999
XK-95 HIGH SPEED MOTOR DRILL SYSTEM
K984035 · HBE
Komet Medical
Neurology · 203d