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
123961–123984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1990
QUICK CHECK 3 FILM
K903191 · CGA
Quantai Biotronics, Inc.
Chemistry · 88d
Cleared Oct 15, 1990
MODEL C286 ISOLETTE INFANT INCUBATOR
K903378 · FMZ
Air-Shields Vickers, Inc.
General Hospital · 77d
Cleared Oct 15, 1990
BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA
K903626 · JJG
Beckman Instruments, Inc.
Chemistry · 66d
Cleared Oct 15, 1990
WILSON-COOK ASPIRATION HANDLE
K903668 · FBK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Oct 15, 1990
QUIDEL ALLERGEN SCREEN POSITIVE CONTROL
K903738 · DGC
Quidel Corp.
Immunology · 60d
Cleared Oct 15, 1990
ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE
K903742 · DHB
Diagnostic Products Corp.
Immunology · 61d
Cleared Oct 15, 1990
MAXI TEST
K904016 · JHI
Bhc Biotech , Ltd.
Chemistry · 41d
Cleared Oct 15, 1990
DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300)
K904100 · CDZ
Diagnostic Systems Laboratories, Inc.
Chemistry · 39d
Cleared Oct 15, 1990
V-TREND TARGET RF TEST
K904105 · DHR
Texas Immunology, Inc.
Immunology · 39d
Cleared Oct 15, 1990
ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
K904168 · CGA
Boehringer Mannheim Corp.
Chemistry · 34d
Cleared Oct 15, 1990
SYNCHRON CX4-CE
K904220 · JJE
Beckman
Chemistry · 33d
Cleared Oct 15, 1990
NOVA LITE TM THYROID
K904224 · JZO
Inova Diagnostics, Inc.
Immunology · 32d
Cleared Oct 15, 1990
HEATWAVE
K904252 · LGZ
Medadvances, Inc.
General Hospital · 28d
Cleared Oct 15, 1990
PROGUARD(TM) BLOOD COLLECTION NEEDLE
K904295 · FMI
Safety-Ject, Inc.
General Hospital · 26d
Cleared Oct 15, 1990
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305 · LCD
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Oct 15, 1990
DUPONT DRUG CALIBRATOR-A
K904306 · JJX
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 26d
Cleared Oct 15, 1990
EUREKA EXTENSION CYLINDERS
K904489 · KPW
Eureka X-Ray Tube Corp.
Radiology · 13d
Cleared Oct 12, 1990
SYB, OR SAVE YOUR BREATH TONGUE CLEANER
K902164 · LCN
P.J., Inc.
Dental · 150d
Cleared Oct 12, 1990
VET (VACUUM ERECTION TECHNOLOGY)
K902240 · LKY
Vetco, Inc.
Gastroenterology & Urology · 147d
Cleared Oct 12, 1990
PULSED SELECTRON
K902533 · JAQ
Nucletron-Oldelft Corp.
Radiology · 126d
Cleared Oct 12, 1990
MILENIA (TM) LH
K902786 · CEP
Diagnostic Products Corp.
Chemistry · 108d
Cleared Oct 12, 1990
LAPAROSCOPIC ACCESS SHEATH SET
K903124 · HET
Cook, Inc.
Obstetrics & Gynecology · 88d
Cleared Oct 12, 1990
HYSTEROSCOPY SHEATH SET
K903146 · HIH
Cook, Inc.
Obstetrics & Gynecology · 86d
Cleared Oct 12, 1990
LAPAROSCOPIC CATHERTER
K903187 · HET
Cook Ob/Gyn
Obstetrics & Gynecology · 85d