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
129745–129768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 09, 1989
USCI CORONARY INFUSION CATHETER
K891069 · DQY
C.R. Bard, Inc.
Cardiovascular · 161d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891114 · LYY
Ambusco Co., Inc.
General Hospital · 160d
Cleared Aug 09, 1989
SHIELDTEX PATIENT EXAMINATION GLOVE (LATEX)
K891263 · LYY
Dah Giap Rubber Industries Sdn Bhd
General Hospital · 154d
Cleared Aug 09, 1989
LATEX EXAMINATION GLOVES
K891445 · LYY
Superior Healthcare Group, Inc.
General Hospital · 147d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891499 · LYY
Promedica Sdn. Bhd.
General Hospital · 146d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVE
K891619 · LYY
Union Rubber Gloves Co., Ltd.
General Hospital · 145d
Cleared Aug 09, 1989
DERMATEC+PLUS(TM)& AMBIDERM(TM) LATEX EXAM GLOVES
K891819 · LYY
Adler Industries, Inc.
General Hospital · 139d
Cleared Aug 09, 1989
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · FRO
Smith & Nephew United, Inc.
General & Plastic Surgery · 152d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892136 · LYY
Beijing Light Industrial Products...
General Hospital · 127d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892148 · LYY
Setia Aircon Sdn. Bhd.
General Hospital · 121d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892472 · LYY
Malatex Industries Sdn. Bhd.
General Hospital · 124d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVE (VINYL)
K892565 · LYZ
Kao Ying Industrial Co., Ltd.
General Hospital · 118d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES (VINYL)
K892607 · LYZ
Disposable Products Co.
General Hospital · 121d
Cleared Aug 09, 1989
UNICATH A
K892849 · IZI
Xre Corp.
Radiology · 113d
Cleared Aug 09, 1989
PATIENT EXAMINATION GLOVES
K893267 · LYY
Hubei Provincial Medicines & Health...
General Hospital · 114d
Cleared Aug 09, 1989
LATEX EXAM GLOVES (MFG. GLOVELINE INDUSTRIES)
K893277 · LYY
China Representatives , Ltd.
General Hospital · 114d
Cleared Aug 09, 1989
PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER
K893644 · JAA
Perkins Mfg. Co.
Radiology · 86d
Cleared Aug 09, 1989
MRT-50A MOBILE
K893750 · LNH
Toshiba Medical Systems
Radiology · 83d
Cleared Aug 09, 1989
ARC-2F ACETABULAR CUP
K893785 · LWJ
Protek, Inc.
Orthopedic · 79d
Cleared Aug 09, 1989
CO2 LASER SYSTEMS & ARTHROGUIDE CO2 LASER FIBER
K893832 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 77d
Cleared Aug 09, 1989
FLEXGARD SYRINGE PROTECTOR
K893862 · FMF
Dr. Gil Del Castillo
General Hospital · 76d
Cleared Aug 09, 1989
VISULIN TRANSPARENT ADHESIVE DRESSING
K894147 · KGX
James River Corp.
General & Plastic Surgery · 56d
Cleared Aug 09, 1989
B-D PATIENT EXAMINATION GLOVES
K894280 · LYY
Bd Becton Dickinson Vacutainer...
General Hospital · 47d
Cleared Aug 09, 1989
LATEX EXAMINATION GLOVES
K894306 · LYY
Ttj Industrial Co. , Ltd.
General Hospital · 49d