FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
127705–127728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 20, 1990
EXCEL STIM II
K896908 · IPF
Excel U.S.A.
Physical Medicine · 71d
Cleared Feb 20, 1990
SKYTRON MODEL 1100 AND MODEL 142
K900290 · JEA
Skytron, Div. the Kmw Group, Inc.
General & Plastic Surgery · 29d
Cleared Feb 20, 1990
DANNIFLEX CPM 880(TM)
K900581 · JFA
Buckman Co., Inc.
Physical Medicine · 13d
Cleared Feb 20, 1990
TRI-SCOOT FRONT WHEEL DRIVE POWERED SCOOTER
K900600 · INI
Invacare Corp.
Physical Medicine · 12d
Cleared Feb 16, 1990
IVEX MODEL NO. BP 3000 BREASTPUMP
K893545 · HGX
Ivex Medical, Inc.
Obstetrics & Gynecology · 284d
Cleared Feb 16, 1990
RHINOTHERM ULTRA 2
K894734 · KFZ
Twinmed Products, Inc.
Anesthesiology · 207d
Cleared Feb 16, 1990
SURGICAL GLOVES
K895018 · KGO
Lon Tai Chemical Industrial Co., Ltd.
General Hospital · 192d
Cleared Feb 16, 1990
CRONEX COMPACT MAMMOGRAPHY CASSETTE
K895335 · IXA
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 169d
Cleared Feb 16, 1990
EXEL SAFELET CATHETER
K895768 · FOZ
Exel Intl.
General Hospital · 143d
Cleared Feb 16, 1990
EXEL HUBER NEEDLE
K895769 · FMI
Exel Intl.
General Hospital · 143d
Cleared Feb 16, 1990
EXEL SPINAL NEEDLES
K895771 · FMI
Exel Intl.
General Hospital · 143d
Cleared Feb 16, 1990
EXEL INDWELLING CATHETER
K895772 · FDZ
Exel Intl.
Gastroenterology & Urology · 143d
Cleared Feb 16, 1990
AUTOPEN
K895890 · FMF
Ulster Scientific, Inc.
General Hospital · 134d
Cleared Feb 16, 1990
CHOLESTEROL TEST KIT
K895951 · CHH
Elite Technology, Inc.
Chemistry · 128d
Cleared Feb 16, 1990
IMAGES-ON-CALL TELERADIOLOGY SYSTEM
K896095 · LMD
Devices & Services Co.
Radiology · 119d
Cleared Feb 16, 1990
WILLIAMS PENILE ANESTHETIC RETAINER
K896160 · FHA
Cook Urological, Inc.
Gastroenterology & Urology · 115d
Cleared Feb 16, 1990
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
K896170 · JHT
Helena Laboratories
Chemistry · 114d
Cleared Feb 16, 1990
COBAS READY URIC ACID REAGENT
K896227 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY CARDIO PROFILE REAGENT STRIP
K896228 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY PROFILE 1 REAGENT STRIP
K896229 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY TOTAL PROTEIN REAGENT
K896230 · CEK
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY TRIGLYCERIDE REAGENT
K896231 · CDT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY LIVER PROFILE REAGENT STRIP
K896233 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY STAT PROFILE REAGENT STRIP
K896234 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 108d