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
85225–85248 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1999
JMS A. V. FISTULA NEEDLE SET
K990470 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 195d
Cleared Aug 30, 1999
JMS APHERESIS NEEDLE
K990510 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 193d
Cleared Aug 30, 1999
XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL
K991237 · MUJ
Radionics, Inc.
Radiology · 140d
Cleared Aug 30, 1999
WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00
K991437 · FRN
Wells Johnson Co.
General Hospital · 126d
Cleared Aug 30, 1999
RENACLEAR DIALYZER CLEANING SYSTEM
K991851 · LIF
Minntech Corp.
Gastroenterology & Urology · 90d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS
K992059 · JWY
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Aug 30, 1999
REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM
K992066 · KPR
GE Medical Systems
Radiology · 73d
Cleared Aug 30, 1999
PASCO MIC AND MIC/ID PANELS (CEFUROXIME)
K992076 · JTN
Pasco Laboratories, Inc.
Microbiology · 70d
Cleared Aug 30, 1999
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH...
K992162 · LZC
Safeskin Corp.
General Hospital · 66d
Cleared Aug 30, 1999
TELEMEDICINE 2000
K992164 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 66d
Cleared Aug 30, 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE
K992223 · LZA
Pamitex Industries Sdn Bhd
General Hospital · 60d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT
K992224 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT
K992241 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT
K992243 · MSV
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Aug 30, 1999
EASY-CURE (CURING AND WHITENING LIGHT)
K992357 · EBZ
Ics of North America, Inc.
Dental · 47d
Cleared Aug 30, 1999
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
K992430 · JJT
Medical Analysis Systems, Inc.
Toxicology · 40d
Cleared Aug 30, 1999
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992463 · LYZ
Shijiazhuang Dilly Plastics Products...
General Hospital · 38d
Cleared Aug 30, 1999
MEDIFIX INC.
K992483 · FAJ
Medifix, Inc.
Gastroenterology & Urology · 35d
Cleared Aug 30, 1999
TOF-WATCH S
K992596 · KOI
Organon Teknika Corp.
Anesthesiology · 27d
Cleared Aug 30, 1999
TOF-WATCH SX
K992598 · KOI
Organon Teknika Corp.
Anesthesiology · 27d
Cleared Aug 27, 1999
REPOSE BONE SCREW SYSTEM
K981677 · LRK
Influence, Inc.
Dental · 472d
Cleared Aug 27, 1999
IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER
K982208 · ITX
Jomed Imaging , Ltd.
Radiology · 430d
Cleared Aug 27, 1999
SEDATELEC ASP ACUPUNCTURE NEEDLES
K983798 · MQX
Sedatelec
General Hospital · 303d
Cleared Aug 27, 1999
DN ACUPUNTURE NEEDLES
K983800 · MQX
Sedatelec
General Hospital · 303d