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
60289–60312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 2007
SYREX HEPARIN LOCK FLUSH SYRINGE, 1 UNIT/ML & 2 UNITS/ML
K061497 · NZW
Excelsior Medical Corp.
General Hospital · 268d
Cleared Feb 23, 2007
CERTAIN PREVAIL DENTAL IMPLANT
K061629 · DZE
Implant Innovations, Inc.
Dental · 256d
Cleared Feb 23, 2007
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · JFY
Wako Chemicals USA, Inc.
Chemistry · 245d
Cleared Feb 23, 2007
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
K061991 · GHR
Helena Laboratories
Hematology · 225d
Cleared Feb 23, 2007
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22
K062263 · CAF
Omron Healthcare, Inc.
Anesthesiology · 203d
Cleared Feb 23, 2007
BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870
K062852 · DYB
Onset Medical Corporation
Cardiovascular · 151d
Cleared Feb 23, 2007
3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870
K063023 · MSH
3M Company
General Hospital · 144d
Cleared Feb 23, 2007
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE
K063100 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 136d
Cleared Feb 23, 2007
CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
K063268 · BZD
Hsiner Co., Ltd.
Anesthesiology · 116d
Cleared Feb 23, 2007
ALEUTIAN SPACER SYSTEM
K063399 · MQP
K2m, Inc.
Orthopedic · 106d
Cleared Feb 23, 2007
EQUINOXE REVERSE SHOULDER SYSTEM
K063569 · PHX
Exactech, Inc.
Orthopedic · 86d
Cleared Feb 23, 2007
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1...
K063608 · MSJ
Dade Behring, Inc.
Chemistry · 81d
Cleared Feb 23, 2007
DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR,...
K063754 · DHA
Dade Behring, Inc.
Chemistry · 66d
Cleared Feb 23, 2007
ABLE GLOVE NITRILE BLUE POWDER FREE EXAMINATION GLOVE
K063777 · LZA
Bright Element Sdn Bhd
General Hospital · 63d
Cleared Feb 23, 2007
POWDERED VINYL PATIENT EXAMINATION GLOVES, YELLOW
K070042 · LYZ
Super Safe Plastic Products Co., Ltd.
General Hospital · 51d
Cleared Feb 23, 2007
PARI HYDRATE G
K070107 · BTT
Pari Innovative Manufacturers, Inc.
Anesthesiology · 43d
Cleared Feb 23, 2007
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K070149 · LYZ
Wuxi Shenzhou Plastic Products Co., Ltd.
General Hospital · 38d
Cleared Feb 23, 2007
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
K070197 · DYB
Acumen Medical, Inc.
Cardiovascular · 32d
Cleared Feb 23, 2007
RETIC-CHEX LINEARITY FOR BC
K070199 · JPK
Streck
Hematology · 32d
Cleared Feb 23, 2007
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE H.0
K070260 · DSI
Philips Medical Systems
Cardiovascular · 28d
Cleared Feb 23, 2007
SIGNATURE EDITION INFUSION SYSTEM, MODELS 710X, 720X
K070268 · FRN
Cardinal Health 303,Inc.
General Hospital · 25d
Cleared Feb 23, 2007
CARDIODAY, VERSION 2.0
K070280 · DQK
Getemed Medizin- Und...
Cardiovascular · 25d
Cleared Feb 23, 2007
HEMOSIL ANTITHROMBIN
K070301 · JBQ
Instrumentation Laboratory CO
Hematology · 23d
Cleared Feb 22, 2007
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
K062388 · BSZ
Docusys
Anesthesiology · 191d