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
137665–137688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 06, 1988
ROPER-TUKE ELBOW
K873660 · JDB
Orthopedic Systems, Inc.
Orthopedic · 118d
Cleared Jan 06, 1988
PALL LEUKOCYTE REMOVAL FILTER, BLOOD
K873666 · CAK
Pall Biomedical Products Co.
General Hospital · 118d
Cleared Jan 06, 1988
PALL LEUKOCYTE REMOVAL FILTER, PLATELETS
K873667 · CAK
Pall Biomedical Products Co.
General Hospital · 118d
Cleared Jan 06, 1988
AUTO SYRINGE MODEL AS20G INFUSION PUMP
K873746 · FRN
Baxter Healthcare Corp
General Hospital · 112d
Cleared Jan 06, 1988
RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT
K873748 · GDW
Deknatel, Inc.
General & Plastic Surgery · 112d
Cleared Jan 06, 1988
IVAC MODEL 560+ SERIES VOLUMETRIC INFUSION PUMP
K873884 · FRN
Y
General Hospital · 105d
Cleared Jan 06, 1988
SET, ADMINISTRATION INTRAVASCULAR
K874467 · FPA
Kendall Mcgaw Laboratories, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED AIRWAY TEMPERATURE SENSOR
K874520 · FLL
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED THERMAL WELL TEMPERATURE SENSOR
K874521 · FLL
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR
K874523 · FLL
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED SUBCUTANEOUS TEMPERATURE SENSOR
K874524 · FLL
Mon-A-Therm, Inc.
General Hospital · 65d
Cleared Jan 06, 1988
MODIFIED FOLEY CATHETER/TEMPERATURE SENSOR
K874525 · KOD
Mon-A-Therm, Inc.
Gastroenterology & Urology · 65d
Cleared Jan 06, 1988
HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR
K874568 · FLL
Mallinckrodt Critical Care
General Hospital · 62d
Cleared Jan 06, 1988
ZEISS VISULAS ARGON LASER
K874609 · HQF
Carl Zeiss, Inc.
Ophthalmic · 58d
Cleared Jan 06, 1988
KIRSCHNER NEER-III MODULAR PROXIMAL HUMERUS
K874643 · HSD
Kirschner Medical Corp.
Orthopedic · 54d
Cleared Jan 06, 1988
MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER
K874930 · DTB
Intermedics, Inc.
Cardiovascular · 35d
Cleared Jan 05, 1988
EBV-EA TEST
K872617 · LSE
Gull Laboratories, Inc.
Microbiology · 183d
Cleared Jan 05, 1988
BETATRON IV SYSTEM
K872774 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 175d
Cleared Jan 05, 1988
URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)
K873371 · CHQ
Bio-Rad
Chemistry · 137d
Cleared Jan 05, 1988
LUMICON
K873893 · JJQ
Hamilton Co.
Chemistry · 104d
Cleared Jan 05, 1988
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
K874033 · JHI
Diagnostic Products Corp.
Immunology · 95d
Cleared Jan 05, 1988
CELL COUNTING GRID GRATICULE
K874190 · IBJ
Portable Medical Laboratories, Inc.
Hematology · 83d
Cleared Jan 05, 1988
THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
K874207 · IBJ
Intl. Remote Imaging Systems
Pathology · 82d
Cleared Jan 05, 1988
MRI STRETCHER
K874332 · FPO
Atomic Products Corp.
General Hospital · 75d