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
141505–141528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1986
MED-PEN/MED-POINT
K853733 · CGA
Garid, Inc.
Chemistry · 454d
Cleared Dec 04, 1986
INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
K861725 · FOZ
Parke-Davis Co.
General Hospital · 212d
Cleared Dec 04, 1986
3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX)
K861985 · MVR
3M Company
General & Plastic Surgery · 196d
Cleared Dec 04, 1986
URINE DIAGNOSTIC REAGENT STRIPS
K862806 · JJB
Amatech International, Inc.
Chemistry · 134d
Cleared Dec 04, 1986
TRANSFERMETER
K863066 · JQF
J. D. Assoc.
Chemistry · 114d
Cleared Dec 04, 1986
SAPPHIRE LASER BLADES (LASER BLADES) ND: YAG
K863086 · GEX
Cooper Lasersonics, Inc.
General & Plastic Surgery · 114d
Cleared Dec 04, 1986
TERUMO SENSIBEAD EIA FSH KIT
K863928 · CGJ
Terumo Medical Corp.
Chemistry · 57d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS ALKALINE PHOSPHATASE TEST
K863980 · CJE
U. S. Diagnostics, Inc.
Chemistry · 51d
Cleared Dec 04, 1986
SUPERCATH I.V. CATHETER
K864038 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 49d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS SERUM CHOLESTEROL TEST
K864081 · CHH
U. S. Diagnostics, Inc.
Chemistry · 45d
Cleared Dec 04, 1986
REFLOTRON(R) ALT (GPT)
K864082 · CKD
Boehringer Mannheim Corp.
Chemistry · 45d
Cleared Dec 04, 1986
ENTERAL ADMINISTRATION ADAPTERS
K864182 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 38d
Cleared Dec 04, 1986
E-Z HOLD WITH ADHESIVE BASE.-#4065
K864188 · KNX
John F. Greer Co., Inc.
Gastroenterology & Urology · 38d
Cleared Dec 04, 1986
ULTRA-GEL - #4083
K864189 · EXB
John F. Greer Co., Inc.
Gastroenterology & Urology · 38d
Cleared Dec 04, 1986
IL TEST 97573-15, PLASMINOGEN ASSAY
K864212 · DDX
Instrumentation Laboratory CO
Hematology · 37d
Cleared Dec 04, 1986
U.S. DIAGNOSTICS ENZYMATIC TRIGLYCERIDE TEST
K864231 · CDT
U. S. Diagnostics, Inc.
Chemistry · 37d
Cleared Dec 04, 1986
SIMPLASTIN EXCEL
K864283 · GJS
Organon Teknika Corp.
Hematology · 35d
Cleared Dec 04, 1986
ZENEX MEDICAL, INC. GAUZE SPONGES
K864298 · EFQ
Zenex Medical, Inc.
General & Plastic Surgery · 34d
Cleared Dec 04, 1986
CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST
K864389 · LJP
American Micro Scan
Microbiology · 28d
Cleared Dec 03, 1986
SANTEST 1AP
K862087 · LKL
Scientific Sales Intl., Inc.
Immunology · 184d
Cleared Dec 03, 1986
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
K862907 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 125d
Cleared Dec 03, 1986
CHOICE CONDOM
K863190 · HIS
Select Sources, Inc.
Obstetrics & Gynecology · 106d
Cleared Dec 03, 1986
SANDHILL AMS
K863312 · FAP
Sandhill
Gastroenterology & Urology · 99d
Cleared Dec 03, 1986
IMMPULSE IGE ASSAY REAGENTS
K863327 · DGP
Sclavo, Inc.
Immunology · 98d