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
103249–103272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1995
MODEL 1001, HYDRODOT(TM) NEUROMONITORING SYSTEM WITH E NET(TM) EEG INTERFACE...
K946318 · GXY
Physiometrix, Inc.
Neurology · 117d
Cleared Apr 24, 1995
ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY)
K950217 · JZO
American Laboratory Products Co., Ltd.
Immunology · 95d
Cleared Apr 24, 1995
LEUKO-TEST
K951101 · DEG
Techlab, Inc.
Immunology · 45d
Cleared Apr 24, 1995
DISPOSABLE & REUSABLE MONOPOLAR HANDSWITHC PENCIL
K951269 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 34d
Cleared Apr 24, 1995
DISPOSABLE PULMONARY FUNCTION FILTER
K951410 · CAH
Creative Biomedics, Inc.
General Hospital · 28d
Cleared Apr 24, 1995
NAVARRE UNIVERSAL DRAINAGE CATHETER
K951475 · GBX
Navarre Biomedical , Ltd.
General & Plastic Surgery · 25d
Cleared Apr 24, 1995
WESTMED BACTERIAL/VIRAL FILTER
K951484 · CAH
Westmed Intl.
General Hospital · 25d
Cleared Apr 24, 1995
DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS
K951491 · CBH
Dale Medical Products, Inc.
Anesthesiology · 24d
Cleared Apr 21, 1995
SAFESHARPE (TM) DISPOSAL SYSTEM
K925056 · FMI
Life Medical Technologies, Inc.
General Hospital · 927d
Cleared Apr 21, 1995
LYSOL I.C. BRAND DISINFECTANT
K940382 · LRJ
National Laboratories
General Hospital · 450d
Cleared Apr 21, 1995
COBAS CORE FREE T3 EIA
K942376 · CEC
Roche Diagnostic Systems, Inc.
Chemistry · 338d
Cleared Apr 21, 1995
SURETEMP
K943695 · FLL
Advanced Bioresearch Assoc.
General Hospital · 266d
Cleared Apr 21, 1995
MODEL# 7500 SURVEYOR
K944611 · MNR
Devilbiss Health Care, Inc.
Anesthesiology · 214d
Cleared Apr 21, 1995
CELSITE(TM) DUAL VENOUS SYSTEM
K945551 · LJT
B. Braun of America, Inc.
General Hospital · 158d
Cleared Apr 21, 1995
HI-TIP HIGH TEMPERATURE REPLACEMENT TIP
K945758 · GEI
Aaron Medical Industries
General & Plastic Surgery · 171d
Cleared Apr 21, 1995
ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY)
K950088 · JZO
American Laboratory Products Co., Ltd.
Immunology · 101d
Cleared Apr 21, 1995
ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY)
K950089 · JZO
American Laboratory Products Co., Ltd.
Immunology · 101d
Cleared Apr 21, 1995
ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY)
K950090 · JZO
American Laboratory Products Co., Ltd.
Immunology · 101d
Cleared Apr 21, 1995
CEDIA DAU PPX/METH CALIBRATOR
K951153 · DLJ
Microgenics Corp.
Toxicology · 38d
Cleared Apr 21, 1995
UROLOGICAL CATHETER & ACCESSORIES
K951178 · FCM
Deroyal Industries, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 21, 1995
PRO-B BIOPSY NEEDLE
K951598 · FCG
Promedical , Ltd.
Gastroenterology & Urology · 14d
Cleared Apr 20, 1995
DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY
K931192 · DEH
Dako Corp.
Immunology · 772d
Cleared Apr 20, 1995
MARQUETTE DEFIB ELECTRODE
K941262 · MKJ
Marquette Electronics, Inc.
Cardiovascular · 400d
Cleared Apr 20, 1995
HP-FAST
K944903 · LYR
Gi Supply
Microbiology · 198d