Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
170161–170184 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1979
H-D-EL
K790372 · LBR
General Diagnostics
Chemistry · 69d
Cleared May 03, 1979
PROGESTERONE
K790440 · JLS
Serono Laboratories, Inc.
Chemistry · 57d
Cleared May 03, 1979
T-3 UPTAKE (MAA) KIT
K790461 · KHQ
Amersham Corp.
Chemistry · 59d
Cleared May 03, 1979
COULTER ACCU-ZYME II GOT REAGENT
K790483 · CIT
Coulter Electronics, Inc.
Chemistry · 55d
Cleared May 03, 1979
AMYLOCHROME STAT SEPARATOR, TEST
K790485 · JKA
Hoffmann-La Roche, Inc.
Chemistry · 52d
Cleared May 03, 1979
THYROXINE RIA KIT
K790495 · CDX
Technia Diagnostics , Ltd.
Chemistry · 51d
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