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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
93097–93120 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 16, 1997
SNT DISPOSABLE BIOPSY NEEDLE
K971247 · HAW
Surgical Navigation Technologies, Inc.
Neurology · 74d
Cleared Jun 16, 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · CFR
Bayer Corp.
Chemistry · 70d
Cleared Jun 16, 1997
SPECIALITY URINE 1,2
K971405 · JJY
Chiron Diagnostics Corp.
Chemistry · 61d
Cleared Jun 16, 1997
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
K971467 · CFR
Carolina Liquid Chemistries Corp.
Chemistry · 55d
Cleared Jun 16, 1997
TOTAL THROXINE MICROPLATE EIA(225-300)
K971709 · KLI
Monobind
Chemistry · 39d
Cleared Jun 16, 1997
TOTAL TRIIODOTHYRONINE(T3) MICROPLATE EIA
K971779 · CDP
Monobind
Chemistry · 33d
Cleared Jun 16, 1997
ACTIVE TESTOSTERONE EIA (DSL-10-4000)
K971823 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 31d
Cleared Jun 16, 1997
ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT
K971902 · LBS
Roche Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Jun 16, 1997
LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600)
K971952 · JJY
Bio-Rad
Chemistry · 19d