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
130369–130392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1989
SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.
K885349 · DXK
Sonotek Corp.
Cardiovascular · 176d
Cleared Jun 22, 1989
PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE
K890292 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 154d
Cleared Jun 22, 1989
BP-8800 BLOOD PRESSURE MONITOR
K890876 · DRT
Colin Medical Instruments Corp.
Cardiovascular · 121d
Cleared Jun 22, 1989
TERUMO AV FISTULA NEEDLE SET
K891062 · FIE
Terumo Medical Corp.
Gastroenterology & Urology · 113d
Cleared Jun 22, 1989
HUGH YOUNG II UROLOGICAL TABLE
K891403 · IZZ
Mallinckrodt Group, Inc.
Radiology · 100d
Cleared Jun 22, 1989
LATEX EXAMINATION GLOVES, STYLE 510 LX
K891418 · LYY
C & K Mfg. & Sales Co.
General Hospital · 100d
Cleared Jun 22, 1989
BUD BRAND PATIENT EXAMINATION GLOVES (VINYL)
K891835 · LYZ
Associated Ent., Inc.
General Hospital · 87d
Cleared Jun 22, 1989
WINFIELD LATEX EXAMINATION GLOVES
K891855 · LYY
Winfield Co., Inc.
General Hospital · 87d
Cleared Jun 22, 1989
TRU-TOUCH VINYL EXAM GLOVES (CANADA)
K891952 · LYZ
Bd Becton Dickinson Vacutainer...
General Hospital · 86d
Cleared Jun 22, 1989
PURAFLEX PATIENT EXAMINATION GLOVES
K892017 · LYY
Medsi, Inc.
General Hospital · 84d
Cleared Jun 22, 1989
HORIZON CENTRAL STATION
K892066 · DRT
Mennen Medical, Inc.
Cardiovascular · 84d
Cleared Jun 22, 1989
PATIENT EXAM GLOVES (MFG. NINGBO MEDICAL LATEX)
K892152 · LYY
Sinochem (Usa), Inc.
General Hospital · 78d
Cleared Jun 22, 1989
NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS
K892204 · LXS
Nidek, Inc.
Ophthalmic · 80d
Cleared Jun 22, 1989
APTT BY HEMOCHRON(R)
K892209 · GFO
Intensive Technology, Inc.
Hematology · 80d
Cleared Jun 22, 1989
REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW
K892214 · HWC
Ace Medical Co.
Orthopedic · 80d
Cleared Jun 22, 1989
MODIFIED GELMAN ARTERIAL FILTER
K892387 · DTM
Gelman Sciences, Inc.
Toxicology · 69d
Cleared Jun 22, 1989
NO. 86500 - ENDOSCOPIC JET WASHER
K892426 · OCX
Superior Healthcare Group, Inc.
Gastroenterology & Urology · 73d
Cleared Jun 22, 1989
KULZER ADHESIVE CEMENT
K892455 · EBF
Kulzer, Inc.
Dental · 73d
Cleared Jun 22, 1989
'EXMOOR' SINGLE USE SUCTION TUBE
K892504 · LRC
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 72d
Cleared Jun 22, 1989
PHONIC EAR ITE/ITC HRNG AID 901, 902, 903, 906,911
K892803 · ESD
United Hearing Systems, Inc.
Ear, Nose, Throat · 66d
Cleared Jun 22, 1989
FORCEPS, SURGICAL, GYNECOLOGICAL
K892820 · HCZ
The South India Surgical Co. Pvt. , Ltd.
Obstetrics & Gynecology · 72d
Cleared Jun 22, 1989
BIOPRIME TM KIT
K892932 · FJK
Hospal
Gastroenterology & Urology · 62d
Cleared Jun 22, 1989
INFRALASE-LASERGUIDE DELIVERY SYSTEM
K892933 · GEX
Ximed Medical Systems
General & Plastic Surgery · 62d
Cleared Jun 22, 1989
REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS
K892937 · JDZ
Dentsply Intl.
Orthopedic · 62d