FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93601–93624 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 17, 1997
AUDALLION III HEARING SYSTEM
K971031 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 17, 1997
DANAVOX MODELS 163/162 BTE
K971032 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 88d
Cleared Jun 17, 1997
DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES
K971065 · GEX
Xintec Corporation
General & Plastic Surgery · 85d
Cleared Jun 17, 1997
HEARTPORT ENDOARTERIAL RETURN CANNULA
K971291 · DWF
Heartport, Inc.
Cardiovascular · 71d
Cleared Jun 17, 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379 · DHR
Boehringer Mannheim Corp.
Immunology · 64d
Cleared Jun 17, 1997
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
K971428 · GGN
Pacific Hemostasis
Hematology · 61d
Cleared Jun 17, 1997
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
K971439 · HQC
Storz Instrument Co.
Ophthalmic · 60d
Cleared Jun 17, 1997
VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE)
K971449 · GIM
Becton Dickinson Vacutainer Systems
Chemistry · 57d
Cleared Jun 17, 1997
CREA OR CREATININE
K971908 · CGX
Carolina Liquid Chemistries Corp.
Chemistry · 25d
Cleared Jun 17, 1997
BUN
K971967 · CDQ
Carolina Liquid Chemistries Corp.
Chemistry · 20d
Cleared Jun 17, 1997
DIASCREEN REAGENT STRIPS
K971976 · LJX
Dia-Screen Corp.
Hematology · 19d
Cleared Jun 16, 1997
NIL - POWDER-FREE LATEX EXAMINATION GLOVES
K961634 · LYY
Hl Rubber Products Sdn Bhd
General Hospital · 413d
Cleared Jun 16, 1997
HIGH RANGE PEROXIDE TEST STRIP
K964264 · FKP
Integrated Biomedical Technology, Inc.
Gastroenterology & Urology · 234d
Cleared Jun 16, 1997
N-ASSAY TIA TRANSFERRIN TEST KIT
K964295 · DDG
Crestat Diagnostics, Inc.
Immunology · 230d
Cleared Jun 16, 1997
ELECSYS CEA ASSAY
K964368 · JIT
Boehringer Mannheim Corp.
Immunology · 227d
Cleared Jun 16, 1997
POWDER-FREE LATEX EXAMINATION GLOVES
K964724 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 213d
Cleared Jun 16, 1997
GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO....
K965044 · LNH
Elscint, Inc.
Radiology · 185d
Cleared Jun 16, 1997
ORTHOSONICS DUO-SON ULTRASOUND DIATHERMY DEVICE
K970131 · IMI
C.L. Mcintosh & Assoc., Inc.
Physical Medicine · 153d
Cleared Jun 16, 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K970150 · LJZ
Zeus Scientific, Inc.
Microbiology · 152d
Cleared Jun 16, 1997
DATEX ENGSTOM MANUAL RESUSCITATOR
K970991 · BTM
Promedic, Inc.
Anesthesiology · 89d
Cleared Jun 16, 1997
ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR...
K971053 · KPO
International Medical Products, Inc.
Gastroenterology & Urology · 84d
Cleared Jun 16, 1997
TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER
K971111 · JKA
Tri-Tech, Inc.
Chemistry · 82d
Cleared Jun 16, 1997
LIQUID N-GENEOUS HDL CHOLESTEROL KIT/CALIBRATOR
K971162 · LBS
Genzyme Corp.
Chemistry · 77d
Cleared Jun 16, 1997
N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
K971190 · LBS
Genzyme Corp.
Chemistry · 77d