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
156553–156576 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 08, 1983
DISPOS. MEDICATION NEBULIZER
K831270 · CAF
Hospitak, Inc.
Anesthesiology · 50d
Cleared Jun 08, 1983
NEY-ORO 60
K831280 · EJT
Deringer-Ney, Inc.
Dental · 57d
Cleared Jun 08, 1983
ULTIPORE PREBYPASS PLUS FILTER
K831286 · KRJ
Pall Biomedical Products Co.
Cardiovascular · 49d
Cleared Jun 08, 1983
PROTOTRO/PROTEOLYTIC ENZYME CONTROL
K831297 · JBQ
American Dade
Chemistry · 48d
Cleared Jun 08, 1983
PEEP SYSTEM D
K831301 · BYE
Draeger Medical, Inc.
Anesthesiology · 48d
Cleared Jun 08, 1983
PBI BHCG RIA KIT
K831302 · JHI
Pacific Biotech, Inc.
Chemistry · 48d