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
137257–137280 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 1988
SHIMADZU CEILING-SUSPENDED C-ARM CH-50
K875374 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU LATERAL C-ARM MH-30
K875375 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-50B
K875376 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU MAMMOGRAPHIC STAND MR-30
K875377 · IZH
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A
K875379 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-10
K875380 · IZI
Shimadzu Precision Instruments, Inc.
Radiology · 43d
Cleared Feb 12, 1988
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
K880247 · BTO
Shiley, Inc.
Anesthesiology · 23d
Cleared Feb 12, 1988
MOBILE PAK, MODEL AC
K880261 · CAW
Intl. Biomedical Concepts, Inc.
Anesthesiology · 21d
Cleared Feb 12, 1988
MOBILE PAK, MODEL DC
K880262 · CAW
Intl. Biomedical Concepts, Inc.
Anesthesiology · 21d
Cleared Feb 11, 1988
MODEL 820 TOP=TRAK
K873039 · BYN
Sierra Laboratories, Inc.
Anesthesiology · 191d
Cleared Feb 11, 1988
WAKO(TM) PRETEST 6A
K873409 · KHE
Wako Chemicals USA, Inc.
Chemistry · 170d
Cleared Feb 11, 1988
MENTOR BLACK LIGHT URETERAL STENT SET
K873557 · FAD
Mentor Corp.
Gastroenterology & Urology · 161d
Cleared Feb 11, 1988
MASK, OXYGEN
K874092 · BYG
Life Support Products, Inc.
Anesthesiology · 126d
Cleared Feb 11, 1988
VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER
K874112 · KOD
Van-Tec, Inc.
Gastroenterology & Urology · 125d
Cleared Feb 11, 1988
DUAL-CURE RADIOPAQUE
K874189 · EBF
Pentron Corp.
Dental · 120d
Cleared Feb 11, 1988
OMNIPLANE 200 FILM CHANGER SYSTEM
K874451 · IZP
Medrad, Inc.
Radiology · 106d
Cleared Feb 11, 1988
P-S MEDICAL VENTRICULAR ACCESS PORT
K874468 · LKG
Pudenz-Schulte Medical Research Corp.
General Hospital · 101d
Cleared Feb 11, 1988
CALCIUM ASSAY KIT, NUMBER 120-19
K874496 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 101d
Cleared Feb 11, 1988
CSF-VENTRICULOSTOMY RESERVOIR
K874498 · LKG
Pudenz-Schulte Medical Research Corp.
General Hospital · 101d
Cleared Feb 11, 1988
MINIMED III INFUSION PUMP & UNI-SET ADMIN SET
K874564 · FRN
Medtronic Minimed
General Hospital · 99d
Cleared Feb 11, 1988
PULSOR, THERAPEUTIC VIBRATOR
K874716 · ISA
Gmg Enterprises, Inc.
Physical Medicine · 86d
Cleared Feb 11, 1988
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT
K874782 · JLX
Diagnostic Products Corp.
Chemistry · 84d
Cleared Feb 11, 1988
OXYGEN SUPPLY CONTROL REGULATOR (OSCR)
K874804 · NFB
Transamerica Products, Inc.
Anesthesiology · 80d
Cleared Feb 11, 1988
HEALTHDYNE RATE METER
K874814 · BZQ
Healthdyne, Inc.
Anesthesiology · 79d