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
166537–166560 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 23, 1980
R2(TM) ECG ELECTRODE SET-#'S305-306 ETC.
K800930 · DRX
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2(TM) ECG CABLE-ADAPTOR #'S 120-121-122
K800931 · DSA
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
ECG-RF-CHOKE CABLE-ADAPTER #'S 121,120
K800932 · DSA
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2 APEX-POST.,ANT.&POST. ELECT.(12 MODS)
K800935 · DRX
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2 PADDLE TYPE CABLE-ADAPTOR #S 170,171
K800936 · LDD
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
R2 PLATE TYPE CABLE-ADAPTOR #S 175,176
K800937 · LDD
R2 Corp.
Cardiovascular · 32d
Cleared May 23, 1980
THAYER-MARTIN AGAR
K800977 · JTY
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
MUELLER HINTIN AGAR W/5% SHEEP BLOOD
K800979 · JTZ
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
HEXTOEN ENTERIC AGAR
K800980 · JSI
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
SALMONELLA SHIGELLA AGAR
K800982 · JSH
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
MACCONKEY AGAR
K800983 · JSI
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
EOSIN METHYLENE BLUE AGAR, LEVINE
K800984 · JSH
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
THIOGLYCOLLATE MED. W/O INDICATOR
K800985 · JSG
Quality Assurance Laboratory, Inc.
Microbiology · 30d
Cleared May 23, 1980
MLT TUBE MICROLARYNGEAL TRACHEAL TUBE)
K801005 · BTR
National Catheter Co. Div. Mallinckrodt
Anesthesiology · 25d
Cleared May 23, 1980
3M R.F. CURRENT SUPPRESSOR
K801041 · DSA
3M Company
Cardiovascular · 21d
Cleared May 23, 1980
DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI
K801051 · CFR
Data Medical Associates, Inc.
Chemistry · 18d
Cleared May 23, 1980
DATA-ZYME GLUCOSE HEXOKINASE UV
K801052 · CFR
Data Medical Associates, Inc.
Chemistry · 18d
Cleared May 23, 1980
LANCER GLUCOSE RATE REAGENT KIT
K801071 · CGA
Sherwood Medical Industries
Chemistry · 17d
Cleared May 23, 1980
CYBREX GENTAMICIN
K801084 · LCQ
Abbott Laboratories
Toxicology · 16d
Cleared May 23, 1980
NEONATAL BREATHING CIRCUIT SYSTEM
K801087 · BZO
Isothermal Systems, Inc.
Anesthesiology · 16d
Cleared May 23, 1980
ROOMMATE-OXYGEN CONCENTRATOR
K801104 · CAW
Cryogenic Assoc.
Anesthesiology · 14d
Cleared May 23, 1980
PEDIATRIC ANESTHESIA CIRCUIT
K801111 · CAI
Vital Signs, Inc.
Anesthesiology · 11d
Cleared May 23, 1980
IL88640 & 88641 CASSETTE-TAPE PROGRAM
K801131 · JQP
Instrumentation Laboratory CO
Toxicology · 11d
Cleared May 23, 1980
USCI INTRALUMINAL GRAFT W/DACRON TIE
K801156 · DSY
C.R. Bard, Inc.
Cardiovascular · 9d