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
139009–139032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 04, 1987
PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
K872228 · FNM
American Pharmaseal Div. Ahsc
General Hospital · 87d
Cleared Sep 04, 1987
INJECT-EASE
K872233 · KZH
Palco Laboratories, Inc.
General Hospital · 86d
Cleared Sep 04, 1987
WHIRLPOOL AERATOR WB700, WB800, WB900, WB975
K872327 · ILJ
Associated Mills, Inc.
Physical Medicine · 79d
Cleared Sep 04, 1987
ICOR NEONATAL HCH
K872371 · BYD
Icor AB
Anesthesiology · 77d
Cleared Sep 04, 1987
MIC MUSHROOM TIP GASTROSTOMY TUBE
K872531 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 70d
Cleared Sep 04, 1987
IRRIGATION PRESSURE MONITOR
K872544 · HRX
Avec Scientific Design Corp.
Orthopedic · 67d
Cleared Sep 04, 1987
SOLCOTRANS CHEST DRAINAGE AUTOTRANSFUSION SYSTEM
K872590 · CAC
Solco Basle, Inc.
Anesthesiology · 65d
Cleared Sep 04, 1987
LASER CENTERING DEVICE
K872747 · HMR
Innomed Corp.
Ophthalmic · 53d
Cleared Sep 04, 1987
AQUATULLE FINE MESH NON-ADHERING DRESSING
K872759 · EFQ
Smith & Nephew, Inc.
General & Plastic Surgery · 53d
Cleared Sep 04, 1987
CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE
K872795 · FPA
Medex, Inc.
General Hospital · 58d
Cleared Sep 04, 1987
TROKEL SINGLE MIRROR YAG LASER LENS
K872802 · LQJ
Ocular Instruments, Inc.
Ophthalmic · 51d
Cleared Sep 04, 1987
SAFETY SYRINGE
K872820 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 50d
Cleared Sep 04, 1987
ULTRA-NEB 99 ULTRASONIC NEBULIZER
K872826 · CAF
The Devilbiss Co.
Anesthesiology · 50d
Cleared Sep 04, 1987
BIOTROL ALPHA AMYLASE
K872831 · CIJ
Biotrol, USA, Inc.
Chemistry · 49d
Cleared Sep 04, 1987
TRACH COLLAR
K872832 · CBH
Rotek Corp.
Anesthesiology · 49d
Cleared Sep 04, 1987
18MM PEYMAN WIDE FIELD YAG LASER LENS
K872855 · HJK
Ocular Instruments, Inc.
Ophthalmic · 49d
Cleared Sep 04, 1987
STRETCH GAUZE BANDAGES
K872875 · NAD
Abco Dealers, Inc.
General & Plastic Surgery · 45d
Cleared Sep 04, 1987
AMERICAN NASAL SPONGE
K872905 · EPP
American Silk Sutures, Inc.
Ear, Nose, Throat · 42d
Cleared Sep 04, 1987
SPECTRO C
K872941 · GGP
Ramco Laboratories, Inc.
Hematology · 39d
Cleared Sep 04, 1987
LOOK SPRING-ASSIST SYRINGES
K872944 · FMF
Look, Inc.
General Hospital · 38d
Cleared Sep 04, 1987
HEARING AID (ALL-IN-THE-EAR)
K873001 · ESD
Littlefield Co.
Ear, Nose, Throat · 31d
Cleared Sep 04, 1987
POREX OTOLOGY INSTRUMENTS
K873044 · LRC
Porex Medical
Ear, Nose, Throat · 31d
Cleared Sep 04, 1987
PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS
K873097 · GBQ
Ipax, Inc.
General & Plastic Surgery · 39d
Cleared Sep 04, 1987
MANUAL OPHTHALMIC SURGICAL INSTRUMENTS
K873099 · HNF
Alcon Laboratories
Ophthalmic · 28d