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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
47233–47256 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 2011
ENTELLUS MEDICAL SINUS GUIDEWIRE
K110739 · LRC
Entellus Medical, Inc.
Ear, Nose, Throat · 89d
Cleared Jun 14, 2011
TEMPFLEX
K110747 · EBG
Kerr Corporation
Dental · 89d
Cleared Jun 14, 2011
AEU-26L ELCTRONIC ENDODONTIC SYSTEM
K111078 · EKX
Aseptico, Inc.
Dental · 57d
Cleared Jun 14, 2011
ADDITIVE CAP
K111217 · KPE
Baxter Healthcare Corp
General Hospital · 43d
Cleared Jun 14, 2011
TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)
K111244 · LJS
Cook, Inc.
General Hospital · 42d
Cleared Jun 13, 2011
ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11
K101990 · GEI
Ethicon Endo-Sugery, LLC
General & Plastic Surgery · 333d
Cleared Jun 13, 2011
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K102458 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 290d
Cleared Jun 13, 2011
AREA-CT, TZ MEDICAL MCOT ECG MONITOR AND ARRHYTHMIA DETECTOR
K102507 · DSI
Tz Medical, Inc.
Cardiovascular · 285d
Cleared Jun 13, 2011
MAX PULSE SYSTEM
K110374 · JOM
Medicore Co., Ltd.
Cardiovascular · 124d
Cleared Jun 13, 2011
MECTALIF
K110927 · MAX
Medacta International
Orthopedic · 77d
Cleared Jun 13, 2011
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K110933 · MAX
Spineology, Inc.
Orthopedic · 70d
Cleared Jun 10, 2011
CUSA NXT EXTENDED LENGTH TIP
K102258 · LFL
Integra Radionics, Inc.
General & Plastic Surgery · 304d
Cleared Jun 10, 2011
NAVIGATOR APPLICATIONS SUITE
K102389 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 291d
Cleared Jun 10, 2011
VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03
K102625 · BZD
Vega Technologies, Inc.
Anesthesiology · 270d
Cleared Jun 10, 2011
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE...
K103584 · DQA
Shenzhen Envisen Industry Co. Limited
Anesthesiology · 185d
Cleared Jun 10, 2011
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K103601 · JJY
Aalto Scientific, Ltd.
Chemistry · 184d
Cleared Jun 10, 2011
DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE
K103736 · FMF
Dmc Medical, Ltd.
General Hospital · 170d
Cleared Jun 10, 2011
DEFENDO Y-OPSY IRRIGATOR
K110088 · ODC
Byrne Medical Incorporated
Gastroenterology & Urology · 149d
Cleared Jun 10, 2011
PRESSURE MANOMETER
K110119 · CAP
Neoforce Group, Inc.
Anesthesiology · 143d
Cleared Jun 10, 2011
EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATATION CATHETER
K110133 · LOX
Creganna-Tactx Medical
Cardiovascular · 143d
Cleared Jun 10, 2011
POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
K110247 · LZA
Jiangsu Dongling Plastic & Rubber...
General Hospital · 133d
Cleared Jun 10, 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
K110248 · LZA
Jiangsu Dongling Plastic & Rubber...
General Hospital · 133d
Cleared Jun 10, 2011
AUTODELFIA NEONATAL IRT KIT
K110274 · JNO
Wallac Oy, A Subsidiary of...
Chemistry · 130d
Cleared Jun 10, 2011
ATLANTIS CROWN ABUTMENT, ATLANTIS GEMINI +(TM) ABUTMENT
K110356 · NHA
Astra Tech, Inc.
Dental · 123d