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
158977–159000 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 21, 1982
FRENZEL EYEGLASSES & RELATED ITEMS
K822179 · KHH
Kelleher Corp.
Ear, Nose, Throat · 60d
Cleared Sep 21, 1982
CELLULOSE ACETATE MEMBRANE STRIPS
K822285 · JJN
Sartorius Filters, Inc.
Chemistry · 53d
Cleared Sep 21, 1982
HEART MONITOR BRACELET ALARM
K822316 · DRI
Hmba
Cardiovascular · 49d
Cleared Sep 21, 1982
DISPOSABLE LINEAR STAPLER (LSF)
K822345 · GDW
Ethicon, Inc.
General & Plastic Surgery · 47d
Cleared Sep 21, 1982
LIFE TRACE 40/42
K822389 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 43d
Cleared Sep 21, 1982
LIFE TRACE 24
K822390 · DRT
Life Science Instrumentation, Inc.
Cardiovascular · 43d
Cleared Sep 21, 1982
TICARCILLIN SYSCEPT. DISKS
K822394 · JTN
Beecham Laboratories
Microbiology · 43d
Cleared Sep 21, 1982
ANA HEP-2 FLUORO-KIT
K822397 · DHN
Clinical Sciences, Inc.
Immunology · 42d
Cleared Sep 21, 1982
LACT-ASSIST BREAST PUMP
K822403 · HGY
Lact-Assist, Inc.
Obstetrics & Gynecology · 42d
Cleared Sep 21, 1982
CONDUCTIVE ADHESIVE DISPERSIVE ELECTRO
K822405 · GEI
Edward Weck, Inc.
General & Plastic Surgery · 42d
Cleared Sep 21, 1982
BIOMEGA MODEL 59W
K822438 · DXN
Bio Mega Diagnostic, Inc.
Cardiovascular · 39d
Cleared Sep 21, 1982
OHIO V5A ANESTHESIA VENTILATOR
K822456 · CBK
Airco/Ohio Medical Products
Anesthesiology · 36d
Cleared Sep 21, 1982
SURGILITE NON-WOVEN WRAP
K822482 · FRG
Surgilite Intl., Inc.
General Hospital · 35d
Cleared Sep 21, 1982
MINITEK GRAM-POSITIVE BROTH & SET AND
K822487 · JSC
Bd Becton Dickinson Vacutainer...
Microbiology · 35d
Cleared Sep 21, 1982
OPTIMIZED UV-GOT REAGENT SET
K822493 · CIT
Biorent Diagnostic, Inc.
Chemistry · 34d
Cleared Sep 21, 1982
OPTIMIZED UV-GPT REAGENT SET
K822494 · CKA
Biorent Diagnostic, Inc.
Chemistry · 34d
Cleared Sep 21, 1982
SERA CHEM SMAC CALIBRATORS
K822496 · JIT
Fisher Scientific Co., LLC
Chemistry · 34d
Cleared Sep 21, 1982
REPCO EASY-BREATHER CLINICAL AIR PUMP
K822512 · BTI
Repcocarts USA, Inc.
Anesthesiology · 29d
Cleared Sep 21, 1982
MODEL #2000 HI-TEMP & #3000 LOW-TEMP
K822513 · GEI
Surgicare Scientific Laboratory, Inc.
General & Plastic Surgery · 32d
Cleared Sep 21, 1982
CSM BETA-LACTAMASE DISC
K822518
Carr-Scarborough Microbiologicals, Inc.
Microbiology · 29d
Cleared Sep 21, 1982
POLYHESIVE PATIENT RETURN ELECTRODE
K822572 · GEI
Valleylab, Inc.
General & Plastic Surgery · 28d
Cleared Sep 21, 1982
QUIKPAGE SCANNER
K822582 · DPS
Agilent Technologies
Cardiovascular · 27d
Cleared Sep 21, 1982
ADVANCE EMIT-CAD QUINIDINE CONTROL
K822587 · DLJ
Syva Co.
Toxicology · 26d
Cleared Sep 21, 1982
VERTEX PERCUTANEOUS PUNCTURE NEEDLE
K822596 · DQO
Vertex Medical Corp.
Cardiovascular · 25d