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
128665–128688 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 17, 1989
IQ LDH
K894578 · CFH
Bd Becton Dickinson Vacutainer...
Toxicology · 85d
Cleared Oct 17, 1989
CORDIS STEERABLE COATED GUIDEWIRE
K894633 · DQX
Cordis Corp.
Cardiovascular · 85d
Cleared Oct 17, 1989
IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM
K894645 · JTC
Dynatech Laboratories, Inc.
Chemistry · 85d
Cleared Oct 17, 1989
PTI INTRA-ART INTERNAL MAMMARY ARTERY CANNULA KIT
K894684 · DWF
Pioneering Technologies, Inc.
Cardiovascular · 84d
Cleared Oct 17, 1989
SOURCERER
K894902 · JJJ
Oakfield Instruments, Ltd.
Toxicology · 77d
Cleared Oct 17, 1989
HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS
K894934 · DKB
Hycor Biomedical, Inc.
Toxicology · 75d
Cleared Oct 17, 1989
CLINISTAT POTASSIUM REAGENT TEST
K895047 · CFM
Heraeus Kulzer, Inc.
Chemistry · 69d
Cleared Oct 17, 1989
SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407
K895118 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 17, 1989
SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406
K895119 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 63d
Cleared Oct 17, 1989
MENTOR DUCTAL CATHETERS
K895285 · GBZ
Mentor Corp.
General & Plastic Surgery · 54d
Cleared Oct 17, 1989
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER
K895313 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 49d
Cleared Oct 17, 1989
ANTI-RNP AND ANTI-SM ANTIBODY TEST
K895338 · LKO
Immco Diagnostics, Inc.
Immunology · 47d
Cleared Oct 17, 1989
SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY
K895380 · CFT
Serono-Baker Diagnostics, Inc.
Chemistry · 48d
Cleared Oct 17, 1989
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA
K895496 · JZG
Incstar Corp.
Chemistry · 69d
Cleared Oct 17, 1989
MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM
K895643 · FDC
Orthoconcept, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 17, 1989
DIAMOND BLADE SURGICAL KNIVES
K895752 · GDM
Magnum Diamond, Inc.
General & Plastic Surgery · 21d
Cleared Oct 17, 1989
TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN
K895808 · DCF
Technicon Instruments Corp.
Immunology · 15d
Cleared Oct 17, 1989
LAN.0800Q/2800Q
K895872 · DBF
Amersham Corp.
Immunology · 13d
Cleared Oct 16, 1989
LIKON
K881777 · IPF
Northwood Intl., Corp.
Physical Medicine · 538d
Cleared Oct 16, 1989
AGAR 4000 NEUROMUSCULAR STIMULATOR
K882387 · IPF
Solcoor, Inc.
Physical Medicine · 493d
Cleared Oct 16, 1989
UNI-STICK PLASTIC LIGATURES
K891331 · EJF
American Orthodontics
Dental · 220d
Cleared Oct 16, 1989
STERILE LATEX SURGEON'S GLOVES
K891404 · KGO
Shinheng Corp.
General Hospital · 216d
Cleared Oct 16, 1989
COPOLYESTER FILM DRESSING
K893647 · KGN
Tri-State Hospital Supply Corp.
General & Plastic Surgery · 154d
Cleared Oct 16, 1989
DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
K893753 · LHK
Bd Becton Dickinson Vacutainer...
Microbiology · 150d