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
139441–139464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 1987
MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT
K870817 · LJT
C.R. Bard, Inc.
General Hospital · 149d
Cleared Jul 30, 1987
RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.
K871795 · LQF
Gen-Probe, Inc.
Microbiology · 84d
Cleared Jul 30, 1987
TOXOPLASMA GONDII IGG ELISA
K871905 · LGD
Electro-Nucleonics Laboratories, Inc.
Microbiology · 76d
Cleared Jul 30, 1987
CORTICAL BONE SCREWS
K872738 · HWC
Military Engineering, Inc.
Orthopedic · 20d
Cleared Jul 30, 1987
SAFE-SEAT, LOW-PROFILE WHEELCHAIR CUSHION
K872739 · KIC
D.A. Schulman, Inc.
Physical Medicine · 21d
Cleared Jul 29, 1987
VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)
K871418 · DXN
Critikon Company, LLC
Cardiovascular · 112d
Cleared Jul 29, 1987
MODIFIED MODEL UA-731 DIGITAL SPHYGMOMANOMETER
K871720 · DSK
A&D Engineering, Inc.
Cardiovascular · 86d
Cleared Jul 29, 1987
MODIFIED SPHYGMOMED NON-INVASIVE BLOOD PRES. MONIT
K871886 · DXN
Draeger Medical, Inc.
Cardiovascular · 76d
Cleared Jul 29, 1987
MODIFIED DIGITAL BLOOD PRESSURE/PULSE METER
K872144 · DXQ
Vestra-Subco, Inc.
Cardiovascular · 55d
Cleared Jul 29, 1987
TB METHYLENE BLUE
K872184 · JTS
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
LIGHT GREEN
K872185 · JTS
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
SULFURIC ACID 10%
K872186 · JTS
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
TB KINYOUN CARBOLFUCHSIN
K872187 · JTS
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
METHANOL, ABSOLUTE
K872189 · JTS
Remel Co.
Pathology · 51d
Cleared Jul 29, 1987
VITEL III, ECG TRANSMITTER
K872229 · DSH
Equimed Corp.
Cardiovascular · 50d
Cleared Jul 29, 1987
T.E.N.S. DEVICE MODEL SPL 2000
K872398 · GZJ
Spartan Laboratories, Inc.
Neurology · 37d
Cleared Jul 29, 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · FRO
Smith & Nephew, Inc.
General & Plastic Surgery · 23d
Cleared Jul 28, 1987
LPM-1 (LASER POWER METER)
K871619 · GEX
Bio-Tek Instruments, Inc.
General & Plastic Surgery · 92d
Cleared Jul 28, 1987
FOCUS-GHB
K871679 · LCP
Awareness Technology, Inc.
Hematology · 90d
Cleared Jul 28, 1987
SOFSWAB
K871879 · EFW
Plastic Engineered Products Co.
Dental · 75d
Cleared Jul 28, 1987
WIDEX HEARING AID MODEL ES6
K872375 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 39d
Cleared Jul 28, 1987
POST-AURICULAR HEARING AID MODEL PE 805CD2
K872473 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 28, 1987
POST-AURICULAR HEARING AID MODEL PE 805 SCD2
K872474 · ESD
Phonic Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 28, 1987
REM500 THREE WHEELED ELEC. CART.
K872518 · INI
Royal Enterprises Manufacturing, Inc.
Physical Medicine · 33d