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

Filters: Cleared only ×
176,076 results
158353–158376 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 08, 1983
SPECTRON PRIMARY STEM FEMORAL PROSTHES
K823727 · JDI
Richard'S Medical Equip., Inc.
Orthopedic · 88d
Cleared Mar 08, 1983
MICRO STIX #011-010-5000 & HOLDER#5100
K823833 · LIB
Dynatech Corp.
Chemistry · 77d
Cleared Mar 08, 1983
CRAFTON ARTHROSCOPY PUMP AP-10
K823848 · HRX
Gambro, Inc.
Orthopedic · 77d
Cleared Mar 08, 1983
MIDDLEBROOK 7H10 AGAR BASE-LOWPH
K823859 · MJD
Gibco Laboratories Life Technologies,...
Microbiology · 76d
Cleared Mar 08, 1983
SELECTIVE LEGIONELLA MEDIA
K823885 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 71d
Cleared Mar 08, 1983
BURN DRESSING
K830089 · NAD
Action Medical Systems, Inc.
General & Plastic Surgery · 56d
Cleared Mar 08, 1983
ABDUCTION PILLOW
K830243 · IOZ
Warm & Form, Orthopedic Materials
Physical Medicine · 42d
Cleared Mar 08, 1983
DEVO'N LOOPS
K830248 · KDC
Devon Industries, Inc.
General & Plastic Surgery · 42d
Cleared Mar 08, 1983
FLORET PEANUT SPONGE/STICK & GAUZE PREP
K830274 · EFQ
Ritmed, Inc.
General & Plastic Surgery · 42d
Cleared Mar 08, 1983
NEEDELET HANDLER FOR SHARPS
K830275 · MMK
Ritmed, Inc.
General Hospital · 42d
Cleared Mar 08, 1983
DUOWIPE CAUTERY TIP & INSTRUMENT CLEANER
K830277 · GEI
Ritmed, Inc.
General & Plastic Surgery · 42d
Cleared Mar 08, 1983
REINFORCED SILICONE TRACHEAL TUBE
K830352 · BTR
Portex, Inc.
Anesthesiology · 33d
Cleared Mar 08, 1983
NEISSERIA IDENTIFICATION DISCS
K830364 · JSX
Oxoid U.S.A., Inc.
Microbiology · 32d
Cleared Mar 08, 1983
POWER FLEX
K830369 · BXB
Biodynamic Technologies of Florida
Physical Medicine · 32d
Cleared Mar 08, 1983
FILDES ENRICHMENT SOLUTON
K830383 · KZI
Gibco Laboratories Life Technologies,...
Microbiology · 32d
Cleared Mar 08, 1983
UREA-PDA DISK
K830396 · JSS
Remel Co.
Microbiology · 29d
Cleared Mar 08, 1983
LIGACLIP TITANIUM LIGATING CLIP
K830503 · FZP
Ethicon, Inc.
General & Plastic Surgery · 20d
Cleared Mar 08, 1983
MILLONIGS MODIFIED PHOSPHATE BUFFERED
K830514 · IFP
Surgipath Medical Industries, Inc.
Pathology · 19d
Cleared Mar 08, 1983
MULTI-SIGNAL AUDITORY STIMULATOR SM700
K830579 · GWJ
Nicolet Biomedical Instruments
Neurology · 13d
Cleared Mar 07, 1983
DOUBLE LUMEN SUBCLAVIAN CATHETER
K823135 · LFJ
Abbott Laboratories
Gastroenterology & Urology · 130d
Cleared Mar 07, 1983
AUTO-TENS MODEL III DUAL CHANNEL REPLACE
K823466 · GZJ
Cbc Corp.
Neurology · 108d
Cleared Mar 07, 1983
RESPITRACE SYSTEM
K823782 · BZK
Respitrace Corp.
Anesthesiology · 82d
Cleared Mar 07, 1983
PARAGON IMMUNOELECTROPHORESIS REAGENT
K823884 · CFF
Beckman Instruments, Inc.
Chemistry · 70d
Cleared Mar 07, 1983
MYOGRAPH 2000
K830058 · BXN
Prothia USA, Inc.
Anesthesiology · 59d