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
151585–151608 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1984
AMER. MEDICAL OPTICS ARGON/KRYPTON LASE
K842250 · HQF
American Medical Optics
Ophthalmic · 77d
Cleared Aug 15, 1984
AMERI. MEDICAL OPTICS ARGON LASER PHOTO
K842251 · HQF
American Medical Optics
Ophthalmic · 77d
Cleared Aug 15, 1984
TDX REA CHOLESTEROL
K842320 · CHH
Abbott Laboratories
Chemistry · 64d
Cleared Aug 15, 1984
ACA BARBITURATES SCREEN/BENZODIAZEPIN
K842386 · DKB
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 58d
Cleared Aug 15, 1984
ACA BENZODIAZEPINES SCREEN TEST PK
K842387 · JXM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 58d
Cleared Aug 15, 1984
DR. GOULD HAND PACK SUSTOM STERIL
K842405 · FRG
Pro-Lab, Inc.
General Hospital · 57d
Cleared Aug 15, 1984
WAKO LDH CII TEST
K842452 · CFH
Wako Chemicals USA, Inc.
Chemistry · 54d
Cleared Aug 15, 1984
SITE SIMCOE STYLE I/A HANDPIECE
K842458 · HQC
Chiron Vision Corp.
Ophthalmic · 54d
Cleared Aug 15, 1984
SITE GILLS STYLE I/A HANDPIECE
K842459
Chiron Vision Corp.
Ophthalmic · 54d
Cleared Aug 15, 1984
PORTABLE ACUIOMETER
K842567 · HLJ
Randwal Instrument Co., Inc.
Ophthalmic · 44d
Cleared Aug 15, 1984
GAUZE & LAB SPONGES STERILE & NON
K842572 · GDY
Ulti-Med Intl., Inc.
General & Plastic Surgery · 43d
Cleared Aug 15, 1984
GILL HEMATOXYLIN STAIN
K842741 · HYJ
E K Ind., Inc.
Pathology · 33d
Cleared Aug 15, 1984
GIEMSA STAIN
K842742 · HYF
E K Ind., Inc.
Hematology · 33d
Cleared Aug 15, 1984
OXYGEN CONCENTRATOR
K842753 · CAW
Bv Medical Equipment Co.
Anesthesiology · 30d
Cleared Aug 15, 1984
SUNBED
K842787 · FTC
Sun Health Systems
General & Plastic Surgery · 27d
Cleared Aug 15, 1984
STREPTEX ZL01
K842828 · JTO
Wellcome Diagnostics
Immunology · 26d
Cleared Aug 15, 1984
ESOPHAGEAL STETHOSCOPE
K842865 · BZW
Inmed Corp.
Anesthesiology · 23d
Cleared Aug 15, 1984
THE SUTURER
K842912
Vlm Surgical, Inc.
General & Plastic Surgery · 21d
Cleared Aug 15, 1984
PATIENT BREATHING CIRCUIT
K843036 · BZO
Infrasonics Corp.
Anesthesiology · 13d
Cleared Aug 14, 1984
CLEAR POROUS PLASTIC-HYPOALLERGENIC
K840948 · GKX
Gainor Medical
Hematology · 39d
Cleared Aug 14, 1984
HEMOCLIP LIGATING CLIPS MED/SML
K841547 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 120d
Cleared Aug 14, 1984
HEMOCLIP LIGATING CLIPS M/LARGE
K841548 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 120d
Cleared Aug 14, 1984
HEMOCLIP AUTOMATIC CLIPS MEDIUM
K841549 · FZP
Edward Weck, Inc.
General & Plastic Surgery · 120d
Cleared Aug 14, 1984
FIRST RESPONSE EMERG. MEDICSL - BURNS
K841898 · FPY
Reed Products, Inc.
General & Plastic Surgery · 99d