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
169321–169344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1979
BIOBRANE BRAND TEMPORARY WOUND DRESSING
K790496 · KGN
Woodroof Laboratories, Inc.
General & Plastic Surgery · 51d
Cleared May 03, 1979
I NETILMICIN RIA KIT
K790514 · JTB
Diagnostic Products Corp.
Toxicology · 49d
Cleared May 03, 1979
THE ABBOTT EXECUTIVE
K790543 · JQP
Abbott Laboratories
Chemistry · 42d
Cleared May 03, 1979
HEATING BLOCK, WAMPOLE 37 C
K790549 · JRG
Armkel, LLC
Chemistry · 44d
Cleared May 03, 1979
BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2
K790687 · JSC
Gibco Laboratories Life Technologies,...
Microbiology · 23d
Cleared May 03, 1979
EMIT-TOX SERUM CALIBRATORS
K790735 · DKB
Syva Co.
Toxicology · 17d
Cleared May 03, 1979
BETA/PAK
K790769 · JOZ
Bio/Data Corp.
Hematology · 14d
Cleared May 03, 1979
ATOMIC ABSORPTION SPECTROPHOTOMETER,
K790780 · JXR
Varian Assoc., Inc.
Toxicology · 10d
Cleared May 03, 1979
SPECTROPHOTOMETER SYSTEM, MODEL AA-475
K790781 · JXR
Varian Assoc., Inc.
Toxicology · 10d
Cleared May 03, 1979
STERILE DEFIBRINATED SHEEP BLOOD
K790801 · JSK
Central Biological Co.
Microbiology · 14d
Cleared May 02, 1979
COIL DIALYSIS, MODELS DM-360 AND DM-360-
K790382 · FKD
Estracorporeal, Inc.
Gastroenterology & Urology · 64d
Cleared May 02, 1979
HD CAPILLARY FILM DIALYZER, MODEL 1001
K790533 · FJG
Travenol Laboratories, S.A.
Gastroenterology & Urology · 48d
Cleared May 02, 1979
HEMODIALYSIS BLOOD CIRCUIT
K790591 · KOC
Travenol Laboratories, S.A.
Gastroenterology & Urology · 37d
Cleared May 01, 1979
DISPOSABLE DIALYZERS, SD-ID, SD-2D
K790308 · FJI
Bentley Laboratories, Inc.
Gastroenterology & Urology · 77d
Cleared May 01, 1979
DATA-ZYME CK CALORIMETRIC/UV PROCEDURE
K790343 · JHS
Data Medical Associates, Inc.
Chemistry · 69d
Cleared May 01, 1979
SZAMYL 6.5
K790474 · CIJ
Worthington Diagnostic Systems
Toxicology · 57d
Cleared May 01, 1979
SERO-STAT STREPTOCOCCUS TEST
K790492 · GTZ
Scott Laboratories, Inc.
Microbiology · 49d
Cleared May 01, 1979
COULTER ACCU-ZYME II GPT REAGENT
K790522 · CKA
Coulter Electronics, Inc.
Chemistry · 53d
Cleared May 01, 1979
AS7 & AS8 MONITORS
K790552 · DRT
Narco Air-Shields
Cardiovascular · 42d
Cleared May 01, 1979
PEPTONE-YEAST EXTRACT BROTH
K790625 · JSC
Anaerobe Systems
Microbiology · 33d
Cleared May 01, 1979
LOMBARD-DOWELL DEOXYRILBONUCLERIC ACID
K790627 · JSH
Anaerobe Systems
Microbiology · 33d
Cleared May 01, 1979
HOWMEDICA BRASS CENTER DISC
K790640 · EHJ
E.C. Moore Co.
Dental · 32d
Cleared May 01, 1979
GDC-685
K790641 · EJS
Deringer-Ney, Inc.
Dental · 32d
Cleared May 01, 1979
MODEL H58-BEHIND-THE-EAR HEARING INSTR.
K790697 · ESD
Marcon Hearing Instruments, Inc.
Ear, Nose, Throat · 21d