FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
132481–132504 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 1989
RESUBMITTED SCANORA
K884650 · IZF
Orion Corp.
Radiology · 129d
Cleared Mar 16, 1989
BIOSONIC ULTRASONIC CLEANING SYSTEM
K884660 · FLG
Whaledent Intl. Div. Ipco
General Hospital · 129d
Cleared Mar 16, 1989
ACS SELECTIVE INFUSION CATHETER
K885237 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 85d
Cleared Mar 16, 1989
EPIDURAL ANESTHESIA TRAY
K885278 · CAZ
Preferred Medical Products
Anesthesiology · 83d
Cleared Mar 16, 1989
SANI-SLEEVE DRAPE FOR DENTAL USE
K885299 · EIA
Nieusma R & D, Inc.
Dental · 79d
Cleared Mar 16, 1989
ELECTRONIC DIGITAL THERMOMETER
K885308 · FLL
Ewig Industries Co. , Ltd.
General Hospital · 79d
Cleared Mar 16, 1989
FEMORAL ANGIOGRAPHY DRAPE
K890101 · KKX
Medical Plastics, Inc.
General Hospital · 65d
Cleared Mar 16, 1989
CYTEX ONE AND CYTEX TWO
K890283 · HHT
Anderson Winn Paper Co.
Obstetrics & Gynecology · 56d
Cleared Mar 16, 1989
NICOLET VIKING II SYSTEM
K890495 · IKN
Nicolet Instrument Corp.
Neurology · 43d
Cleared Mar 16, 1989
TSH MICROASSAY
K890579 · JLW
Diamedix Corp.
Chemistry · 38d
Cleared Mar 16, 1989
STUART TITANIUM SURGICAL MESH
K890601 · EZX
Stuart
General & Plastic Surgery · 38d
Cleared Mar 16, 1989
EMPI ISLAND TENS ELECTRODE
K890605 · GXY
Empi
Neurology · 38d
Cleared Mar 16, 1989
IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)
K890609 · CGS
Intl. Immunoassay Laboratories, Inc.
Chemistry · 37d
Cleared Mar 16, 1989
EMPI MULTIDAY TENS DISPOSABLE ELECTRODE
K890614 · GXY
Empi
Neurology · 37d
Cleared Mar 16, 1989
CRYPTOSPORIDIUM CONTROL SLIDE
K890670 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 35d
Cleared Mar 16, 1989
BETA-2 MICROGLOBULIN EIA
K890694 · JZG
Serex, Inc.
Immunology · 34d
Cleared Mar 16, 1989
RIA-GNOST FERRITIN
K890697 · JMG
Cambridge Medical Technology
Immunology · 34d
Cleared Mar 16, 1989
GRAM STAIN CONTROL SLIDE
K890718 · LJG
Scientific Device Laboratory, Inc.
Microbiology · 31d
Cleared Mar 16, 1989
EMPI REUSEABLE PIN-STYLE TENS ELECTRODE
K890747 · GXY
Empi
Neurology · 31d
Cleared Mar 16, 1989
STARTRAC
K890793 · IOL
Unisen, Inc.
Physical Medicine · 27d
Cleared Mar 16, 1989
RIA-GNOST PROGESTERONE
K890836 · JLS
Cambridge Medical Technology
Chemistry · 23d
Cleared Mar 16, 1989
EIA READER MODEL EL301
K890854 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 23d
Cleared Mar 16, 1989
ABUSCREEN FP FOR CANNABINOIDS
K890887 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 23d
Cleared Mar 16, 1989
PLAKOF
K890910 · JET
Ximex, Ltd.
Dental · 21d