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

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176,076 results
68209–68232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 02, 2004
MPS MYOCARDIAL PROTECTION SYSTEM - MPS 2 CONSOLE, MODEL 5201260
K041979 · DTR
Quest Medical, Inc.
Cardiovascular · 41d
Cleared Sep 02, 2004
SAMARITAN PAD PAK DEFIBRILLATION ELECTRODE, MODEL SPP-301
K042088 · MKJ
Heartsine Technologies, Inc.
Cardiovascular · 30d
Cleared Sep 02, 2004
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO...
K042187 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 21d
Cleared Sep 02, 2004
LOW FLOW OSV II HYDROCEPHALUS VALVE
K042192 · JXG
Integra Neurosciences Implants S.A.
Neurology · 21d
Cleared Sep 02, 2004
SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE
K042247 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 14d
Cleared Sep 01, 2004
SHINMED MODE SW-988 UNTRASONIC NEBULIZER
K031370 · CAF
Shining World Health Care Co., Ltd.
Anesthesiology · 490d
Cleared Sep 01, 2004
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
K033491 · DAP
Roche Diagnostics Corp.
Hematology · 302d
Cleared Sep 01, 2004
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
K041502 · JOZ
Haemoscope Corp.
Hematology · 86d
Cleared Sep 01, 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
K041533 · HWC
Synthes (Usa)
Orthopedic · 85d
Cleared Sep 01, 2004
ZIMMER TRABECULAR METAL HUMERAL STEM
K041549 · KWT
Zimmer, Inc.
Orthopedic · 84d
Cleared Sep 01, 2004
TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM
K041637 · ITX
Envisioneering, LLC
Radiology · 76d
Cleared Sep 01, 2004
RESOLUTION THROMBECTOMY SYSTEM, MODEL EV-2
K041705 · QEY
Omnisonics Medical Technologies
Cardiovascular · 70d
Cleared Sep 01, 2004
INFINITY TRIDENT NMT POD
K042003 · KOI
Draeger Medical Systems, Inc.
Anesthesiology · 37d
Cleared Sep 01, 2004
POWER SCOOTER, MODEL TL-688
K042010 · INI
Teh Lin Prosthetic & Orthopaedic, Inc.
Physical Medicine · 37d
Cleared Sep 01, 2004
R&D CBC-XE HEMATOLOGY CONTROL
K042094 · JPK
R&D Systems, Inc.
Hematology · 29d
Cleared Sep 01, 2004
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
K042182 · FPA
Icu Medical, Inc.
General Hospital · 21d
Cleared Sep 01, 2004
SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE
K042229 · JAK
Siemens Medical Solution, Inc. USA
Radiology · 15d
Cleared Aug 31, 2004
PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO-...
K032831 · DQA
Conmed Corporation
Anesthesiology · 355d
Cleared Aug 31, 2004
DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420
K040380 · DQA
Dolphin Medical, Inc.
Anesthesiology · 196d
Cleared Aug 31, 2004
LIFECLINIC, MODEL 2400
K040562 · DXN
Lifeclinic International, Inc.
Cardiovascular · 181d
Cleared Aug 31, 2004
SKIN LEVEL GASTROSTOMY TUBE KIT (ECSL)
K041034 · KNT
Entracare, LLC
Gastroenterology & Urology · 132d
Cleared Aug 31, 2004
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089 · MQV
Biomet Manufacturing, Inc.
Orthopedic · 127d
Cleared Aug 31, 2004
PRE-POWDERED VINYL EXAM GLOVES
K041379 · LYZ
Shijiazhuang Wally Plastics Co., Ltd.
General Hospital · 99d
Cleared Aug 31, 2004
REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T
K041778 · DXN
Maxi-Aids, Inc.
Cardiovascular · 61d