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
165361–165384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 28, 1980
L-15T ENDOCARDIAL PACING ELECTRODE
K802689
Coratomic, Inc.
Cardiovascular
Cleared Oct 27, 1980
EMPTY TRANSFER BAGS
K802671
Delmed, Inc.
General & Plastic Surgery
Cleared Oct 27, 1980
OCCUPAK CAT.#200-0538
K802691
Occumedics, Inc.
Ophthalmic
Cleared Oct 23, 1980
PACEPATH MODEL 819
K801417 · DTB
Pacesetter Systems
Cardiovascular · 129d
Cleared Oct 23, 1980
LEAD, ENDOCARDIAL, TINED, BIPOLAR, 5MM
K801455 · DTB
Pacesetter Systems
Cardiovascular · 121d
Cleared Oct 23, 1980
COMBOSTAT - NO-BOIL KIT
K801578 · CDD
Ria Products, Inc.
Hematology · 106d
Cleared Oct 23, 1980
VITAMIN B12 - NO-BOIL KIT
K801579 · CDD
Ria Products, Inc.
Hematology · 106d
Cleared Oct 23, 1980
GAMMA COAT(125 I) RUBELLA ANTIBODY
K801667 · GOL
Clinical Assays, Inc.
Microbiology · 94d
Cleared Oct 23, 1980
U.I. OCTOSON
K801675 · LEJ
Ausonics Pty , Ltd.
Radiology · 93d
Cleared Oct 23, 1980
IMED DROP RATE CALCULATOR #340
K801734 · FLN
Imed Corp.
General Hospital · 90d
Cleared Oct 23, 1980
IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC.
K801792 · DTB
Telectronics, Inc.
Cardiovascular · 86d
Cleared Oct 23, 1980
UNIVERSAL TEMP. PACING ELECT. #080-10000
K801800 · LDF
Medical Testing System, Inc.
Cardiovascular · 86d
Cleared Oct 23, 1980
TENCKHOFF CATHETER
K801818 · FJS
Sil-Med Corp.
Gastroenterology & Urology · 84d
Cleared Oct 23, 1980
MEDELA ELECTRIC BREAST PUMP
K801862 · HGX
Medela, Inc.
Obstetrics & Gynecology · 79d
Cleared Oct 23, 1980
KLINAR REAGENT PAK, #36010
K801892 · JGT
Hi Chem, Inc.
Chemistry · 76d
Cleared Oct 23, 1980
TEMP STERNUM SAW
K801914 · DWI
Temp Medical Products, Inc.
General & Plastic Surgery · 73d
Cleared Oct 23, 1980
MULTICHANNEL TELEMETRY SYSTEM
K801944 · DRG
Burdick Corp.
Cardiovascular · 70d
Cleared Oct 23, 1980
EXTERNAL, TEMP. PORTABLE CARDIAC GENER
K801953 · DTE
Telectronics, Inc.
Cardiovascular · 66d
Cleared Oct 23, 1980
FTA-ABS TEST
K801959 · JWL
Immuno-Diagnostic Products, Inc.
Microbiology · 65d
Cleared Oct 23, 1980
CMV TEST KIT
K801963 · GQH
Immuno-Diagnostic Products, Inc.
Microbiology · 65d
Cleared Oct 23, 1980
IN-LINE SCAN HEAD MODIFICATION MARK III
K801971 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 65d
Cleared Oct 23, 1980
TRUE SPECTRUM ANALYSIS/MARK IV DUPLEX
K801972 · IYN
Advanced Technology Laboratories, Inc.
Radiology · 65d
Cleared Oct 23, 1980
IN-LINE SCAN HEAD MARK IV DUPLEX ULTRA
K801973 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 65d
Cleared Oct 23, 1980
SCOTT NEEDLE & SCOTT MICK IMPLANTER
K801983 · IWJ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 65d