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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
154201–154224 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 1984
RICO RESPIRATION MONITOR
K840975 · BZK
J.M. Laboratories, Inc.
Anesthesiology · 24d
Cleared Mar 30, 1984
RIONET HEARING AID HB-71M
K841012 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 30, 1984
TOP DISPOSABLE INFUSION SET
K841025 · FPA
Top Surgical Manufacturers Co.
General Hospital · 18d
Cleared Mar 30, 1984
REMBRANDT SHADE MODIFICATION KIT
K841111 · EBF
Den-Mat Corp.
Dental · 15d
Cleared Mar 30, 1984
NEBULO 28 NEBULIZER KIT
K841158 · BTT
Inspiron Corp.
Anesthesiology · 11d
Cleared Mar 29, 1984
DOUBLE & SINGLE TANTALUM CLIPS
K840207 · HQW
Storz Instrument Co.
Ophthalmic · 70d
Cleared Mar 29, 1984
IRRIGATION, ASPIRATION TUBING SETS
K841072 · HQC
Innovative Surgical Products, Inc.
Ophthalmic · 17d
Cleared Mar 27, 1984
IMAGE DEFLECTOR
K833669 · HPA
Michael Onufryk
Ophthalmic · 161d
Cleared Mar 27, 1984
POROCOAT HPS II HIP PROSTHESIS
K833681 · LPH
Depuy, Inc.
Orthopedic · 147d
Cleared Mar 27, 1984
SHILEY DISPOS. TEMP. PROBES
K833981 · FLL
Shiley, Inc.
General Hospital · 131d
Cleared Mar 27, 1984
PDI PREPMASTER WET PACK PATIENT PREP KIT
K840342 · FRG
Nice-Pak Products, Inc.
General Hospital · 81d
Cleared Mar 27, 1984
PDI PREPMASTER WET PACK VAGINAL-X21477
K840343 · KGO
Nice-Pak Products, Inc.
General Hospital · 81d
Cleared Mar 27, 1984
I.V. START KIT
K840619 · FPA
Marwood Medical, Inc.
General Hospital · 42d
Cleared Mar 27, 1984
PULSELIFE STIMULATOR
K840983 · BWK
Pulse Life, Inc.
Neurology · 21d
Cleared Mar 27, 1984
ACUPUNCTURE INSOLES
K840995 · BWK
Lu LU Enterprise Co. , Ltd.
Neurology · 19d
Cleared Mar 26, 1984
PDI PREPMASTER WET PACK MINOR PROCEDURE
K840344 · FRG
Nice-Pak Products, Inc.
General Hospital · 80d
Cleared Mar 26, 1984
MANNITOL SALT AGAR
K841134 · JSI
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
MYCOSEL AGAR W/CHLORAMPHENICOL &
K841135 · JSJ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
SABOURAUD DEXTROSE AGAR W/CHLORAMPHE
K841136 · JSJ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
MUELLER HINTON AGAR W/WO BLOOD
K841137 · JTZ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
COLUMBIA AGAR W/COLISTIN, NALADIXIC
K841139 · JSJ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
PHENYLETHYL ALCOHOL BLOOD AGAR
K841140 · JSJ
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
MACCONKEY AGAR
K841141 · JSI
Anaerobe Systems
Microbiology · 10d
Cleared Mar 26, 1984
COLUMBIA AGAR W/5% SHEEP BLOOD
K841143 · JSG
Anaerobe Systems
Microbiology · 10d