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
130969–130992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 22, 1989
SINGLE USE VINYL EXAM GLOVES - COLOR CODED
K892976 · LYZ
Phoenix Medical Technology, Inc.
General Hospital · 71d
Cleared Jun 22, 1989
HPI NON STERILE EXAM GLOVES
K893018 · LYY
Tillotson Corp.
General Hospital · 71d
Cleared Jun 22, 1989
GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
K893135 · JOL
Premium Plastics, Inc.
General Hospital · 58d
Cleared Jun 22, 1989
PROTHROMBIN TIME (PT) BY HEMOCHRON
K893378 · GJS
International Technidyne Corp.
Hematology · 52d
Cleared Jun 22, 1989
DESERET PRN ADAPTER
K893406 · KGZ
Deseret Medical, Inc.
General & Plastic Surgery · 51d
Cleared Jun 22, 1989
SURGIFRESH SUB-MICRON MASK NO. 901008-000
K893417 · FXX
Texas Medical Products, Inc.
General Hospital · 51d
Cleared Jun 22, 1989
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
K893452 · IZZ
Warner-Lambert Co.
Radiology · 50d
Cleared Jun 22, 1989
FIBEROPTIC HEADLIGHT SYSTEM
K893458 · EBA
Cuda Products Co.
Dental · 51d
Cleared Jun 22, 1989
MODEL M2-150/I-150/M2-150T/M3-150/M2-150,300-300
K893491 · FST
Cuda Products Co.
General & Plastic Surgery · 49d
Cleared Jun 22, 1989
CUFF SPECULUM
K893531 · KPL
Mountain Medical Equipment, Inc.
Gastroenterology & Urology · 45d