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
115729–115752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 13, 1992
CO2 INSUFFLATION TUBING
K922038 · HIF
Surgeon Surgical Instrumentation, Inc.
Obstetrics & Gynecology · 165d
Cleared Oct 13, 1992
ENCORE SS-A
K922157 · LLL
Clark Laboratories, Inc.
Immunology · 159d
Cleared Oct 13, 1992
GRICE SOFT TISSUE BIOPSY KIT
K922161 · KNW
Ideal Medical, Inc.
Gastroenterology & Urology · 159d
Cleared Oct 13, 1992
ZEPPELIN MOTOR DRILL SYSTEM
K922299 · HBE
Von Zeppelin Chirurgische Instrumente...
Neurology · 151d
Cleared Oct 13, 1992
THE ADVANCE SERIES FROM HILL-ROM
K922352 · FNL
Hill-Rom, Inc.
General Hospital · 147d
Cleared Oct 13, 1992
PAIN-EEZ
K922690 · GZJ
International Center For Nutritional...
Neurology · 131d
Cleared Oct 13, 1992
API UNISCEPT KB/TYPE 2 AND 3
K922926 · JWY
Analytical Products, Inc.
Microbiology · 118d
Cleared Oct 13, 1992
NOVA NA/K/CL/LI MODULE
K922943 · CEM
Nova Biomedical Corp.
Chemistry · 117d
Cleared Oct 13, 1992
KING DIAGNOSTICS UREA NITROGEN REAGENT
K922969 · CDN
King Diagnostics, Inc.
Chemistry · 116d
Cleared Oct 13, 1992
MICRO 100,200,300, & 400 TENS
K923298 · GZJ
Skylark Device Co., Ltd.
Neurology · 99d
Cleared Oct 13, 1992
ELECTROSURGICAL ELECTRODES
K923332 · GEI
Premier Dental Products Co.
General & Plastic Surgery · 98d
Cleared Oct 13, 1992
DBA FOCAL CHANGE FRAMES
K923415 · HQZ
Focal Change
Ophthalmic · 95d
Cleared Oct 13, 1992
MICROLITE MICROTITER PLATE LUMINOMETER ML3000
K923456 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 91d
Cleared Oct 13, 1992
COMPACOLOR
K923472 · EBF
Wilde-USA, Inc.
Dental · 91d
Cleared Oct 13, 1992
MULTIQUAL UNASSAYED PRODUCTS
K923632 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Oct 13, 1992
MULTIQUAL ASSAY PRODUCTS
K923633 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 84d
Cleared Oct 13, 1992
COX DISPOSABLE POLYPECTOMY SNARES
K923671 · FDI
Cox Medical Ent., Inc.
Gastroenterology & Urology · 83d
Cleared Oct 13, 1992
ACCUDATA GLUCOSE TEST STATION
K924475 · CGA
Boehringer Mannheim Corp.
Chemistry · 40d
Cleared Oct 13, 1992
ACUFEX FIXATION POST
K924514 · HWC
Acufex Microsurgical, Inc.
Orthopedic · 39d
Cleared Oct 13, 1992
CREATINE KINASE (CK) TEST ITEM #65411
K924704 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Oct 09, 1992
COMBISON(R) 330, MODEL # IR17.5AG/A & VRW177AK/A
K904070 · IYO
Kretztechnik AG
Radiology · 766d
Cleared Oct 09, 1992
NIBP 9225 COMBI
K912815 · DXN
S & W Medico Teknik
Cardiovascular · 491d
Cleared Oct 09, 1992
ELITE II ELECTROCARDIOGRAPH,MODIFIED
K915327 · LOS
Siemens Burdick, Inc.
Cardiovascular · 318d
Cleared Oct 09, 1992
ENDO-GARD ELECTROSURGICAL TROCAR
K915790 · GCJ
Conmedcorp
General & Plastic Surgery · 290d