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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
124345–124368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1990
SAFETY INJECTION PORT
K903541 · FPA
Du-Call Miller Plastics, Inc.
General Hospital · 38d
Cleared Sep 14, 1990
CINTEX
K903605 · ILQ
Nanopac, Inc.
Physical Medicine · 37d
Cleared Sep 14, 1990
OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305
K903650 · HWE
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 32d
Cleared Sep 14, 1990
OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229
K903713 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 31d
Cleared Sep 14, 1990
GOLD GATORS
K903729 · DRY
Lead-Lok, Inc.
Cardiovascular · 29d
Cleared Sep 13, 1990
TEFLON CERVICAL ACCESS SET
K896701 · HDQ
Cook Ob/Gyn
Obstetrics & Gynecology · 289d
Cleared Sep 13, 1990
EUB-515 DIAGNOSTIC ULTRASOUND DEVICE
K897042 · IYO
Hitachi Medical Corp. of America
Radiology · 269d
Cleared Sep 13, 1990
SERIM RESIDUAL CHLORINE TEST KIT
K901734 · FKJ
Serim Research Corp.
Gastroenterology & Urology · 149d
Cleared Sep 13, 1990
PDS-2000
K902653 · EIK
Intl. Equipment and Supply Corp.
Dental · 90d
Cleared Sep 13, 1990
DIAGNOSTIC ULTRASOUND/URO-GYN UDS 1002
K902692 · FAP
Diagnostic Ultrasound Corp.
Gastroenterology & Urology · 86d
Cleared Sep 13, 1990
SYNERMED GLUCOSE REAGENT KIT
K903063 · CGA
Synermed, Inc.
Chemistry · 66d
Cleared Sep 13, 1990
MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL
K903664 · HBE
Micro-Aire Surgical Instruments, Inc.
Neurology · 30d
Cleared Sep 13, 1990
KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD
K903884 · KWL
Kinamed, Inc.
Orthopedic · 23d
Cleared Sep 13, 1990
KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD
K903885 · KWL
Kinamed, Inc.
Orthopedic · 23d
Cleared Sep 13, 1990
CALCIUM ARSENAZO III REAGENT
K903896 · CIC
Trace Scientific , Ltd.
Chemistry · 21d
Cleared Sep 13, 1990
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
K904007 · KHS
Amresco, Inc.
Chemistry · 15d
Cleared Sep 12, 1990
VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER
K895597 · FOZ
Vas-Cath, Inc.
General Hospital · 359d
Cleared Sep 12, 1990
KAWASUMI Y-TYPE BLOOD ADMINISTRATION SET
K896892 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI I.V. ADMINISTRATION SET WITH BURETTE
K896893 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI BLOOD ADMINISTRATION SET
K896894 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI I.V. ADMINISTRATION SET
K896895 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
KAWASUMI SMALL VEIN INFUSION SET
K896896 · FPA
Kawasumi Laboratories Co., Ltd.
General Hospital · 278d
Cleared Sep 12, 1990
DYNASTY HEARING SYSTEMS INSTRUMENT
K900632 · ESD
Alastair Granville-Jackson, Mfa, Ed.D.
Ear, Nose, Throat · 216d
Cleared Sep 12, 1990
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
K900966 · HGL
Hitachi Medical Corp. of America
Obstetrics & Gynecology · 195d