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
139033–139056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1987
UNIFAST GAMMA-GT
K873135 · JQB
Sclavo, Inc.
Chemistry · 25d
Cleared Sep 04, 1987
PERSONNA DISPOSABLE SCALPEL
K873142 · GES
American Safety Razor Co.
General & Plastic Surgery · 25d
Cleared Sep 04, 1987
TREACE MAGNUM OTO-TOOL SYSTEM
K873154 · ERL
Treace Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 04, 1987
VAN DELLEN RETROBULBAR NEEDLE
K873162 · HMX
Van Dellen, Ltd.
Ophthalmic · 24d
Cleared Sep 04, 1987
VAN DELLEN IRRIGATING CYSTOTOME
K873163 · HNY
Van Dellen, Ltd.
Ophthalmic · 24d
Cleared Sep 04, 1987
VAN DELLEN HEALON CANNULA
K873164 · HMX
Van Dellen, Ltd.
Ophthalmic · 24d
Cleared Sep 04, 1987
SURGICAL DRAPE
K873313 · KKX
American Medical Technology, Inc.
General Hospital · 18d
Cleared Sep 04, 1987
HORN CUSTOM AID
K873338 · ESD
Hearing Aids by Guy Horn
Ear, Nose, Throat · 16d
Cleared Sep 03, 1987
CRT PORTABLE EMERGENCY OXYGEN INHALATOR
K872170 · CAN
Cost Reduction Technologies, Inc.
Anesthesiology · 87d
Cleared Sep 03, 1987
SIEMENS O2-AIR MIXER 965
K872278 · BZR
Siemens Elema AB
Anesthesiology · 80d
Cleared Sep 03, 1987
SONOPULS 464, ULTRASOUND THERAPY EQUIPMENT
K872394 · IMG
Henley Intl.
Physical Medicine · 83d
Cleared Sep 03, 1987
LAKE CATHETER CARE KIT
K872750 · KOD
Lake Medical Products, Inc.
Gastroenterology & Urology · 52d
Cleared Sep 02, 1987
DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT
K871328 · LHL
E.I. Dupont DE Nemours & Co., Inc.
Microbiology · 152d
Cleared Sep 02, 1987
QUICK QUALITATIVE CALCIUM TEST (QUICK-CAL)
K871903 · JFN
Creative Scientific Technology, Inc.
Chemistry · 110d
Cleared Sep 02, 1987
ALLEGRO(TM) HUMAN CHORIONIC GONADOTROPIN IM SYSTEM
K872390 · JHI
Nichols Institute Diagnostics
Chemistry · 75d
Cleared Sep 02, 1987
PARAMAX URINE/CSF CALIBRATOR
K872789 · JIX
American Dade
Chemistry · 50d
Cleared Sep 02, 1987
CYBERFLUOR 615 IMMUNOANALYZER
K872803 · KHO
Cyberfluor, Inc.
Chemistry · 49d
Cleared Sep 02, 1987
ACROMED SCREW DRIVER
K873066 · HXX
Buckman Co., Inc.
Orthopedic · 28d
Cleared Sep 02, 1987
ACROMED BONE SCREW TAP SLEEVES
K873067 · HWX
Buckman Co., Inc.
Orthopedic · 28d
Cleared Sep 02, 1987
MULTI ANALYTE MIXTURES, CALIBRATORS
K873116 · JIX
Biotrol, USA, Inc.
Chemistry · 23d
Cleared Sep 02, 1987
BIOTROL REFERENCE
K873118 · JIX
Biotrol, USA, Inc.
Chemistry · 23d
Cleared Sep 02, 1987
BIOTROL MAGNESIUM CALMAGITE
K873180 · JGJ
Biotrol, USA, Inc.
Chemistry · 21d
Cleared Sep 02, 1987
ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT
K873310 · CGX
Abbott Laboratories
Chemistry · 15d
Cleared Sep 01, 1987
CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
K870804 · DTR
American Bentley
Cardiovascular · 186d