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
151033–151056 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1984
ACTH RIA
K844181 · CKG
Syncor Intl. Corp.
Chemistry · 32d
Cleared Nov 27, 1984
BIOTIS ANAEROBIC KBE AGAR
K844195 · JSI
Otisville Biotech, Inc.
Microbiology · 28d
Cleared Nov 27, 1984
MOSS LIMB LOAD MONITOR LM101-1
K844202 · IKE
Moss Rehabilation Hospital
Physical Medicine · 28d
Cleared Nov 27, 1984
RICH-MAR DELTA 330 HV
K844217 · IMG
Rich-Mar Corp.
Physical Medicine · 27d
Cleared Nov 27, 1984
RHINOMANOMETER A440 DIGITAL
K844230 · BXQ
Center Laboratories, Inc.
Anesthesiology · 26d
Cleared Nov 27, 1984
SGPT REAGENT SET
K844283 · CKD
Livonia Diagnostics, Inc.
Chemistry · 22d
Cleared Nov 27, 1984
CUSTOM LITE
K844321 · HQG
Buchmann Optical Industries
Ophthalmic · 21d
Cleared Nov 27, 1984
SGOT REAGENT SET
K844322 · CIQ
Livonia Diagnostics, Inc.
Chemistry · 20d
Cleared Nov 23, 1984
BONE STAPLING FIXATION SYS
K840566 · JDR
3M Company
Orthopedic · 289d
Cleared Nov 23, 1984
PHARMA-PLAST SUCTION SET TYPE YANKAUER
K843468 · GEA
Zimmar Consulting , Ltd.
General & Plastic Surgery · 78d
Cleared Nov 23, 1984
PDB II VIBRATING DRAINAGE BED
K843572 · JFB
Invacare Corp.
Physical Medicine · 73d
Cleared Nov 23, 1984
HEALTH PULSE FA-222 POWER MUSCLE STIMUL
K843638 · IPF
Therapeutic Equipment Corp.
Physical Medicine · 67d
Cleared Nov 23, 1984
KARECO INT'L WHEELCHAIR
K843688 · IOR
Kareco Intl., Inc.
Physical Medicine · 65d
Cleared Nov 23, 1984
ISOSTATION ANKLE/SUBTALAR MACHINE A-100
K844060 · IKK
Isotechnologies, Inc.
Physical Medicine · 36d
Cleared Nov 23, 1984
VANISH ORTHODONTIC BRACKET
K844067 · EJF
A Company, Inc.
Dental · 36d
Cleared Nov 23, 1984
EIXO THERMUS HEATING PADS
K844224 · IMD
Eixo Thermus
Physical Medicine · 22d
Cleared Nov 23, 1984
ARK TONGUE CLEANER
K844291 · LCN
Arkay Co.
Dental · 18d
Cleared Nov 23, 1984
MEDI-TECH DILATATION CATHETERS
K844292 · LCN
Medi-Tech, Inc.
Dental · 18d
Cleared Nov 23, 1984
ORAL IRRIGATION TIP
K844318 · EFS
Pro Pulse, Inc.
Dental · 17d
Cleared Nov 21, 1984
OPERAID SURGICAL DRAIN
K841721 · HOZ
Jedmed Instrument Co.
Ophthalmic · 210d
Cleared Nov 21, 1984
OPERAID NUCLEUS
K841807 · KYG
Jedmed Instrument Co.
Ophthalmic · 204d
Cleared Nov 21, 1984
NORTA SILICONIZED LATEX BALLOON CATH.
K842420 · KOD
Beiersdorf, Inc.
Gastroenterology & Urology · 154d
Cleared Nov 21, 1984
AUTOMATED INTRAOCULAR SCISSORS
K842471 · HQE
Medical Instrument Development...
Ophthalmic · 149d
Cleared Nov 21, 1984
BRILLETTE MODEL
K842835 · HOI
Cillus Company, Inc.
Ophthalmic · 124d