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
129577–129600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 18, 1989
NIDEK MODEL YC-1200
K893987 · LXS
Nidek, Inc.
Ophthalmic · 74d
Cleared Aug 18, 1989
MADEGOM LTDA. PENROSE DRAIN TUBING
K894119 · GBW
Madegom
General & Plastic Surgery · 67d
Cleared Aug 18, 1989
EXUSORB TRANSPARENT DRESSING
K894274 · KGX
Controlled Therapeutics Corp.
General & Plastic Surgery · 57d
Cleared Aug 18, 1989
STRYKER TRAUMA TRAY
K894470 · KYZ
Stryker Corp.
General Hospital · 31d
Cleared Aug 18, 1989
THE AUTOLET LITE
K894474 · FMK
Ulster Scientific, Inc.
General & Plastic Surgery · 31d
Cleared Aug 18, 1989
DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE
K894728 · HRX
Dyonics, Inc.
Orthopedic · 23d
Cleared Aug 18, 1989
CLOTHINGUARD
K894760 · FYE
Barrier Concepts, Inc.
General & Plastic Surgery · 22d
Cleared Aug 18, 1989
OR TOWEL PACKS
K894764 · KKX
Advance Medical Designs, Inc.
General Hospital · 22d
Cleared Aug 18, 1989
SURGICAL CHISEL/OSTEOTOME
K894785 · KDG
Fdt Precision Machine Co., Inc.
General & Plastic Surgery · 22d
Cleared Aug 17, 1989
LIFECARE MICRO PUMP
K883645 · FRN
Abbott Laboratories
General Hospital · 357d
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