Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
65257–65280 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 04, 2005
ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO
K051890 · JZO
Roche Diagnostics Corp.
Immunology · 23d
Cleared Aug 04, 2005
OPTIMA SPINAL SYSTEM
K051971 · KWQ
U&I Corp.
Orthopedic · 14d
Cleared Aug 03, 2005
KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+
K030146 · NVK
Kavo America
Dental · 931d
Cleared Aug 03, 2005
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
K050994 · BZD
Cardinalhealth
Anesthesiology · 106d
Cleared Aug 03, 2005
ABBOTT AXSYM B12
K051327 · CDD
Abbott Laboratories
Chemistry · 75d
Cleared Aug 03, 2005
POWDER-FREE BLUE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY...
K051378 · LZA
Medline
General Hospital · 69d
Cleared Aug 03, 2005
CML 1000
K051437 · FPA
Icu Medical, Inc.
General Hospital · 63d
Cleared Aug 03, 2005
AMS PELVIC FLOOR REPAIR SYSTEM
K051485 · OTO
American Medical Systems, Inc.
Obstetrics & Gynecology · 58d
Cleared Aug 03, 2005
COBALT G HV BONE CEMENT
K051532 · LOD
Biomet, Inc.
Orthopedic · 55d
Cleared Aug 03, 2005
BEAUTIFIL FLOW
K051818 · EBF
Shofu Dental Corp.
Dental · 29d
Cleared Aug 03, 2005
AVISO OPHTHALMIC ULTRASOUND SYSTEM
K051851 · IYO
Quantel Medical
Radiology · 26d
Cleared Aug 03, 2005
POWDER-FREE VINYL EXAM GLOVES
K052006 · LYZ
Baoding Guanzhong Glove Co., Ltd.
General Hospital · 9d
Cleared Aug 02, 2005
DIAGNODENT PERIO TIP (ACCESSORY)
K042394 · NBL
Kavo America Corporation
Dental · 334d
Cleared Aug 02, 2005
SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30
K051045 · FRN
Spectrx, Inc.
General Hospital · 99d
Cleared Aug 02, 2005
GLUCOLAB BLOOD GLUCOSE MONITORING SYSTEM
K051285 · CGA
Infopia Co, Ltd.
Chemistry · 77d
Cleared Aug 02, 2005
CARLO SURGICAL GOWN
K051426 · FYA
Sofilm Technology Co., Ltd.
General Hospital · 62d
Cleared Aug 02, 2005
SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64
K051618 · MOS
Midwest Rf, LLC
Radiology · 46d
Cleared Aug 02, 2005
AS-OBGYN INFORMATION SYSTEM
K051639 · LLZ
As Software, Inc.
Radiology · 43d
Cleared Aug 02, 2005
VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0
K051649 · LLZ
Camtronics Medical Systems
Radiology · 42d
Cleared Aug 02, 2005
STARPACS DENTAL
K051715 · LLZ
Infinitt Co., Ltd.
Radiology · 36d
Cleared Aug 02, 2005
VENTRI
K051855 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 25d
Cleared Aug 02, 2005
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)
K051935 · LYZ
Shijiazhuang Wonder Plastic Co., Ltd.
General Hospital · 18d
Cleared Aug 02, 2005
ACHIEVA 1.5T & INERA 1.5T FAMILY
K052013 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 7d
Cleared Aug 01, 2005
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · CAH
Fisher &Paykel Healthcare , Ltd.
General Hospital · 110d