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
137401–137424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1988
ELECTROSTIM I.F.
K873566 · LIH
Promatek Industries, Ltd.
Neurology · 152d
Cleared Feb 01, 1988
ACID PHOSPHATASE (KINETIC) CAT. # 320-06
K875209 · CKB
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 45d
Cleared Feb 01, 1988
BIOTROL URIC ACID ENZYMATIQUE UV H.P.
K875320 · CDO
Biotrol, USA, Inc.
Chemistry · 34d
Cleared Feb 01, 1988
EDEC 60 R/F
K875341 · IZO
Electromed Intl., Ltd.
Radiology · 33d
Cleared Jan 29, 1988
SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE
K873533 · DSI
Medical Electronics Laboratories, Inc.
Cardiovascular · 150d
Cleared Jan 29, 1988
VES-TEMP MODEL VT1 MONOPLACE COOL/HEAT SYSTEM
K873546 · DWJ
Reimers Engineering, Inc.
Cardiovascular · 150d
Cleared Jan 29, 1988
NAMIC HAWKINS UNIVERSAL DRAINAGE SET
K873954 · FGE
North American Instrument Corp.
Gastroenterology & Urology · 123d
Cleared Jan 29, 1988
ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE
K874020 · KPF
Abbott Laboratories
Gastroenterology & Urology · 119d
Cleared Jan 29, 1988
ANGIO WASTE FLUIDS DUMP BAG
K874037 · DQO
Procedure Products, Inc.
Cardiovascular · 116d
Cleared Jan 29, 1988
ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD
K874183 · DTB
Daig Corp.
Cardiovascular · 108d
Cleared Jan 29, 1988
MODEL DMC-75 MINI-CATHETER SET
K874307 · FPA
Life-Tech Intl., Inc.
General Hospital · 101d
Cleared Jan 29, 1988
HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE
K874514 · FLL
Mallinckrodt Critical Care
General Hospital · 88d
Cleared Jan 29, 1988
MODIFIED ESOPHAGEAL STETHOSCOPE/TEMPERATURE SENSOR
K874519 · BZW
Mon-A-Therm, Inc.
Anesthesiology · 88d
Cleared Jan 29, 1988
MODIFIED MYOCARDIAL TEMPERATURE SENSOR
K874522 · KRB
Mon-A-Therm, Inc.
Cardiovascular · 88d
Cleared Jan 29, 1988
NEPHROSS I.Q. ANDANTE
K874549 · FJI
Organon Teknika Corp.
Gastroenterology & Urology · 86d
Cleared Jan 29, 1988
KEELER ACU 22XT OPHTHALMIC CRYO UNIT
K874555 · HPS
Keeler Instruments, Inc.
Ophthalmic · 86d
Cleared Jan 29, 1988
PATIENTWATCH (TM)
K874571 · DSH
Advanced Medical Technology, Inc.
Cardiovascular · 85d
Cleared Jan 29, 1988
MOORE HIP PROSTHESIS SOLID STEM
K874599 · JDI
Orthopedic Systems, Inc.
Orthopedic · 81d
Cleared Jan 29, 1988
MOORE HIP PROSTHESIS FENESTRATED STEM
K874616 · JDI
Orthopedic Systems, Inc.
Orthopedic · 81d
Cleared Jan 29, 1988
HEALTHDYNE APNEA/HEART MONITOR, MODEL 900
K874695 · DRT
Healthdyne, Inc.
Cardiovascular · 74d
Cleared Jan 29, 1988
CAPILLARY FLOW DIALYZERS
K874728 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 72d
Cleared Jan 29, 1988
BIPOLATOR 50
K874779 · GEI
Treace Medical, Inc.
General & Plastic Surgery · 71d
Cleared Jan 29, 1988
OMED WOUND CLOSURE STRIPS
K874813 · FPX
Oxboro Medical Intl., Inc.
General & Plastic Surgery · 66d
Cleared Jan 29, 1988
REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE
K874901 · JAA
Fischer Imaging Corp.
Radiology · 59d