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

Filters: Cleared only ×
176,076 results
157393–157416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 1983
BIO-PROBE SYSTEM-BLOOD FLOW PROBE
K830858 · DPT
Bio Medicus, Inc.
Cardiovascular · 83d
Cleared Jun 08, 1983
AP-CHECK
K830877 · GYA
General Devices
Neurology · 82d
Cleared Jun 08, 1983
BICARBONATE/VARIABLE SODIUM KIT-DM-367
K830908 · FKQ
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 79d
Cleared Jun 08, 1983
DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON
K831012 · CHL
Fisher Scientific Co., LLC
Chemistry · 70d
Cleared Jun 08, 1983
DIAGNOSTICS PO 2 ELECTROLYTE
K831013 · CHL
Fisher Scientific Co., LLC
Chemistry · 70d
Cleared Jun 08, 1983
HEMOGLOBIN ELECTROPHORESIS METH ON THE-
K831055 · JBO
Olympus Corp.
Hematology · 68d
Cleared Jun 08, 1983
SAF FIXATIVE
K831058 · LDW
American Micro Scan
Pathology · 68d
Cleared Jun 08, 1983
TRICHROME STAIN
K831060 · JTS
American Micro Scan
Pathology · 68d
Cleared Jun 08, 1983
PVA FIXATIVE/FORMALIN
K831061 · LDZ
American Micro Scan
Pathology · 68d
Cleared Jun 08, 1983
SECTIONING AID KIT
K831065 · KEW
Technicon Instruments Corp.
Pathology · 65d
Cleared Jun 08, 1983
UNIVERSAL INSTRU. SET FOR NEUROVASCULAR
K831071 · GZX
Prothia USA, Inc.
Neurology · 65d
Cleared Jun 08, 1983
JURGAN PIN BALL
K831072 · LYT
Jurgan Development & Mfg., Ltd.
Orthopedic · 65d
Cleared Jun 08, 1983
SYNEVAC VACUUM SOURCE UNIT
K831085 · BTA
Synemed, Inc.
General & Plastic Surgery · 65d
Cleared Jun 08, 1983
HEMATOXYLIN GILL FORMULATION IX#56016
K831090 · HYJ
Accra Laboratories, Inc.
Pathology · 65d
Cleared Jun 08, 1983
PARA LASAR
K831094 · JPK
Streck Laboratories, Inc.
Hematology · 65d
Cleared Jun 08, 1983
CASE WRIGHT-GIEMSA STAIN PAK
K831131 · HYF
Case Instruments
Pathology · 63d
Cleared Jun 08, 1983
AMEBIASIS BIO-ENZABEAD SCREEN KIT
K831133 · KHW
Bionetic Laboratory Products
Immunology · 62d
Cleared Jun 08, 1983
DOUBLE BOW TOOTH SEPARATOR
K831136 · JEP
Almore Intl., Inc.
Dental · 62d
Cleared Jun 08, 1983
DADE HEMATOLOGY CALIBRATOR
K831140 · KRX
American Dade
Hematology · 62d
Cleared Jun 08, 1983
ULTRAKIT
K831172 · HQC
Staar Surgical Co.
Ophthalmic · 58d
Cleared Jun 08, 1983
GAUZE SPONGE-NON-STERILE SPONGE
K831182 · EFQ
Den Med, Inc.
General & Plastic Surgery · 58d
Cleared Jun 08, 1983
GAUZE SPONGE STERILE SPONGE
K831183 · EFQ
Den Med, Inc.
General & Plastic Surgery · 58d
Cleared Jun 08, 1983
BHCG RIA KIT
K831264 · JHI
Micromedic Systems
Chemistry · 51d
Cleared Jun 08, 1983
VINYLAC PRESS-PACK DENTURE RESIN
K831269 · EBI
Astron Dental Corp.
Dental · 51d