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
130177–130200 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1989
USCI PROBING CATHETER
K890152 · DQY
C.R. Bard, Inc.
Cardiovascular · 216d
Cleared Aug 17, 1989
USCI PROBE LINX EXTENSION WIRE
K890404 · DQX
C.R. Bard, Inc.
Cardiovascular · 205d
Cleared Aug 17, 1989
USCI PTA BALLOON DILATATION CATHETER
K890405 · LIT
C.R. Bard, Inc.
Cardiovascular · 205d
Cleared Aug 17, 1989
PHOENIX DRAPES WITH MICROBAN
K890917 · KGX
Phoenix Medical Technology, Inc.
General & Plastic Surgery · 175d
Cleared Aug 17, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892268 · LYY
Jinnwah Ent., Inc.
General Hospital · 134d
Cleared Aug 17, 1989
IFA SENSIBAC NALIDIXIC ACID
K892713 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 125d
Cleared Aug 17, 1989
IFA SENSIBAC KANAMYCIN
K892733 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 125d
Cleared Aug 17, 1989
IFA SENSIBAC CEPHALOTIN
K892735 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 125d
Cleared Aug 17, 1989
PATIENT EXAMINATION GLOVES
K892974 · LYY
Dubo Latex , Ltd.
General Hospital · 127d
Cleared Aug 17, 1989
HI LATEX EXAMINATION GLOVES
K893046 · LYY
Hansa Intl., Inc.
General Hospital · 126d
Cleared Aug 17, 1989
LATEX EXAMINATION GLOVES
K893325 · LYY
Hin Fatt Corp. Sdn Bhd
General Hospital · 120d
Cleared Aug 17, 1989
CENTRALITE BACKPOINTER
K893398 · IWE
Diacor, Inc.
Radiology · 108d
Cleared Aug 17, 1989
SHIELDS T.C. LASER LENS
K893731 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 92d
Cleared Aug 17, 1989
RECEPTAL (R) SAF-GARD(TM) SUCTION LINER
K893741 · GCX
Abbott Laboratories
General Hospital · 92d
Cleared Aug 17, 1989
AMYLASE TEST (AML) ITEM NUMBER: 65404
K893751 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 90d
Cleared Aug 17, 1989
COAT-A-COUNT (TM) FSH IRMA
K893976 · CGJ
Diagnostic Products Corp.
Microbiology · 76d
Cleared Aug 17, 1989
TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE
K894084 · DQY
Target Therapeutics
Cardiovascular · 70d
Cleared Aug 17, 1989
OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
K894185 · DXY
Telectronics Pacing Systems, Inc.
Cardiovascular · 62d
Cleared Aug 17, 1989
C.A.B. RING
K894268 · MAB
Medi-Sharp, Inc.
Cardiovascular · 56d
Cleared Aug 17, 1989
LATEX EXAMINATION GLOVES
K894635 · LYY
Ever-More Latex Products Sdn Bhd
General Hospital · 27d
Cleared Aug 17, 1989
STERILE LATEX EXAM GLOVES
K894676 · LYY
Superior Healthcare Group, Inc.
General Hospital · 24d
Cleared Aug 17, 1989
SYSTEM 2500 MEDICAL WATERBED
K894723 · IOQ
Dermanetics Corp.
Physical Medicine · 23d
Cleared Aug 15, 1989
IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT
K882674 · LKH
Icn Immunobiologicals
Microbiology · 413d
Cleared Aug 15, 1989
GONOSTAT
K883486 · LSL
Technology Management & Marketing, Inc.
Microbiology · 364d