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
141553–141576 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1987
E-Z JECT INSULIN SYRINGE
K870018 · FMF
Can-Am Surgical Corp.
General Hospital · 33d
Cleared Feb 04, 1987
IV SECUREMENT DEVICE
K870020 · KGX
Avery Intl.
General & Plastic Surgery · 33d
Cleared Feb 04, 1987
SKYTRON MODEL 610-2
K870045 · INX
Skytron, Div. the Kmw Group, Inc.
Physical Medicine · 30d
Cleared Feb 04, 1987
T1365 (BIRD SEED AGAR SLANT)
K870057 · JSI
Lakewood Biochemical Co., Inc.
Microbiology · 28d
Cleared Feb 04, 1987
IV SECUREMENT DEVICE USING HYTREL THERMO. FILM
K870090 · KGX
Avery Intl.
General & Plastic Surgery · 26d
Cleared Feb 04, 1987
IV SECUREMENT DEVICE USING PCCE THERMO. FILM
K870091 · KGX
Avery Intl.
General & Plastic Surgery · 26d
Cleared Feb 04, 1987
SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM
K870122 · KKX
Avery Intl.
General Hospital · 23d
Cleared Feb 04, 1987
SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM
K870123 · KKX
Avery Intl.
General Hospital · 23d
Cleared Feb 04, 1987
SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM
K870124 · KKX
Avery Intl.
General Hospital · 23d
Cleared Feb 04, 1987
EXTREMITY ELEVATOR
K870125 · HST
Orthopedic Systems, Inc.
Neurology · 23d
Cleared Feb 04, 1987
MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE
K870134 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared Feb 04, 1987
KULTSURE
K870231 · LIO
Ncs Diagnostics, Inc.
Microbiology · 14d
Cleared Feb 03, 1987
INJET-100, FLUID INJECTOR
K861582 · KZE
Injet Medical Products, Inc.
General Hospital · 280d
Cleared Feb 03, 1987
2120 NON-INVASIVE BLOOD PRESSURE MONITOR W/CUFF
K861987 · DXN
Ohmeda Medical
Cardiovascular · 257d
Cleared Feb 03, 1987
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
K862226 · DXY
Pacesetter Systems
Cardiovascular · 237d
Cleared Feb 03, 1987
MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER
K862383 · DSB
Rjl Systems, Inc.
Cardiovascular · 224d
Cleared Feb 03, 1987
OTT DISINFECTOR FOR FLEXIBLE ENDOSCOPES
K862402 · NVE
Medivators, Inc.
General Hospital · 223d
Cleared Feb 03, 1987
LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC
K862462 · BZQ
Nihon Kohden America, Inc.
Anesthesiology · 218d
Cleared Feb 03, 1987
CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR
K863100 · DPS
Honeywell, Inc.
Cardiovascular · 174d
Cleared Feb 03, 1987
TECA/MEDELEC AUDIOSTAR
K863156 · GWJ
Teca, Inc.
Neurology · 169d
Cleared Feb 03, 1987
COOK-VPI CONTINENCE CUFF
K863227 · FHA
Cook Urological, Inc.
Gastroenterology & Urology · 166d
Cleared Feb 03, 1987
LEECO VIS-CUBE STREP A (EIA)
K864170 · GTZ
Leeco Diagnostics, Inc.
Microbiology · 102d
Cleared Feb 03, 1987
PENLON CIRCLE SYSTEM
K864588 · CAI
Bear Medical Systems, Inc.
Anesthesiology · 74d
Cleared Feb 03, 1987
VAPLOK
K864605 · CAD
Bear Medical Systems, Inc.
Anesthesiology · 71d