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
138745–138768 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 1987
A.R.M. (ASPEN RETURN MONITOR)
K873591 · GEI
Qmed, Inc.
General & Plastic Surgery · 26d
Cleared Sep 30, 1987
TENS LEAD
K873608 · GZI
Desco Industries, Inc.
Neurology · 22d
Cleared Sep 30, 1987
NONPRESCRIPTION SUNGLASSES
K873685 · HQY
Arcotoys, Inc.
Ophthalmic · 16d
Cleared Sep 30, 1987
LEUKOCLIP(R)
K873744 · FZQ
Beiersdorf, Inc.
General & Plastic Surgery · 14d
Cleared Sep 29, 1987
ADMS TRANSRECTAL 7.5 MHZ PROBE
K870967 · ITX
Diasonics, Inc.
Radiology · 203d
Cleared Sep 29, 1987
ARTHRO AUTOMAT 5002
K871180 · HRX
F.M. Wiest USA, Inc.
Orthopedic · 188d
Cleared Sep 29, 1987
ARTHROCOMBI 5003
K871181 · HRX
F.M. Wiest USA, Inc.
Orthopedic · 188d
Cleared Sep 29, 1987
G-GT STANDARD CALIBRATOR
K871759 · JIT
Wako Chemicals USA, Inc.
Chemistry · 147d
Cleared Sep 29, 1987
SPINOSCOPE
K872836 · IKN
Diagnospine Fabrication, Inc.
Neurology · 74d
Cleared Sep 29, 1987
EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
K872852 · LCP
Sandare Chemical Co., Inc.
Hematology · 71d
Cleared Sep 29, 1987
QTEST STREP
K872961 · GTZ
Quidel Corp.
Microbiology · 62d
Cleared Sep 29, 1987
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K873171 · JHX
American Dade
Chemistry · 49d
Cleared Sep 29, 1987
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA
K873186 · CEP
Serono Diagnostics, Inc.
Chemistry · 48d
Cleared Sep 29, 1987
TELSTAR MODEL PP
K873210 · ESD
Telstar Electronics, Inc.
Ear, Nose, Throat · 46d
Cleared Sep 29, 1987
SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL
K873318 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE
K873319 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD
K873320 · KZI
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300
K873321 · KZI
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088
K873322 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 42d
Cleared Sep 29, 1987
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
K873350 · LAR
Em Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Sep 29, 1987
QBC VENOUS BLOOD CONTROL/MULTIPLE
K873354 · JPK
R&D Systems, Inc.
Hematology · 40d
Cleared Sep 29, 1987
QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
K873467 · DIF
Quantimetrix Medical Industries
Chemistry · 32d
Cleared Sep 29, 1987
CUSTOM IN-THE-EAR HEARING AID SERIES MCA20
K873468 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 32d
Cleared Sep 29, 1987
UTERINE INJECTOR 2MM
K873515 · HES
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 29d