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
138433–138456 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1987
INFANT MONITOR, MODEL 2400
K872631 · BZQ
Arvee Medical, Inc.
Anesthesiology · 112d
Cleared Oct 26, 1987
MODEL 7200A WITH PULSE OXIMETRY
K873065 · DQA
Puritan Bennett Corp.
Anesthesiology · 82d
Cleared Oct 26, 1987
GAMBRO BICART SYSTEM
K873155 · FKP
Gambro, Inc.
Gastroenterology & Urology · 77d
Cleared Oct 26, 1987
DISPOSABLE, MANUAL PULMONARY RESUSCITATOR
K873286 · BTM
Hospitak, Inc.
Anesthesiology · 70d
Cleared Oct 26, 1987
ELECTROBLOC TRANS. ELECTRICAL NERVE BLOCK GENERA.
K873357 · GZJ
Th Charters, Inc.
Neurology · 67d
Cleared Oct 26, 1987
NICOLET EXPERT SLEEP/WAKE ANALYSIS SYSTEM
K873535 · GWQ
Nicolet Biomedical Instruments
Neurology · 55d
Cleared Oct 26, 1987
MPG-50 X-RAY GENERATOR
K873544 · IZO
Thomson-Cgr Medical Corp.
Radiology · 55d
Cleared Oct 26, 1987
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · DPS
Quinton, Inc.
Cardiovascular · 52d
Cleared Oct 26, 1987
SURGICAL PENCIL/ ELECTROSURGICAL PENCIL
K873595 · GEI
Yuntek International, Inc.
General & Plastic Surgery · 52d
Cleared Oct 26, 1987
ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL
K873688 · JXH
Dentsply Intl.
Neurology · 46d
Cleared Oct 26, 1987
CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL
K873689 · GXP
Dentsply Intl.
Neurology · 45d
Cleared Oct 26, 1987
CEDAR(TM) PELVIC CUSHION
K873690 · LWG
Cedar Surgical, Inc.
General & Plastic Surgery · 48d
Cleared Oct 23, 1987
MICROS(TM)
K871995 · FPA
Controlled Release Technologies, Inc.
General Hospital · 150d
Cleared Oct 23, 1987
DHEA-S RIA KIT
K872879 · JKC
Endocrine Associates, Inc.
Chemistry · 94d
Cleared Oct 23, 1987
MODEL 1330 EXTENSION SET
K873042 · FPA
Pharmacia Deltec, Inc.
General Hospital · 80d
Cleared Oct 23, 1987
SODIUM/POTASSIUM REAGENT KIT
K873126 · JGS
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
CHLORIDE REAGENT KIT
K873127 · JFS
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
GLUCOSE REAGENT KIT
K873128 · CGA
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
CARBON DIOXIDE REAGENT KIT
K873129 · JFL
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
WASH SOLUTION KIT
K873130 · JJE
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
CREATININE REAGENT KIT
K873131 · CGX
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
BUN REAGENT KIT
K873132 · LFP
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
LASER RESISTANT DRAPE
K873141 · KKX
Baxter Healthcare Corp
General Hospital · 74d
Cleared Oct 23, 1987
AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT
K873197 · JWH
Depuy, Inc.
Orthopedic · 71d