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

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176,076 results
155713–155736 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 28, 1983
RESPIRATORY FLOW MODULE
K833265 · JAX
Thoratec Laboratories Corp.
Anesthesiology · 68d
Cleared Nov 28, 1983
NATURELLE-LITE
K833279 · EIS
Genesis Industries, Inc.
Dental · 67d
Cleared Nov 28, 1983
RX D PENTRON
K833281 · EIS
Genesis Industries, Inc.
Dental · 67d
Cleared Nov 28, 1983
RX NYSP PENTRON 60
K833282 · EIS
Genesis Industries, Inc.
Dental · 67d
Cleared Nov 28, 1983
RX ORY PENTRON C & B
K833283 · EIS
Genesis Industries, Inc.
Dental · 67d
Cleared Nov 28, 1983
RX 41 PENTRON 41
K833284 · EIS
Genesis Industries, Inc.
Dental · 67d
Cleared Nov 28, 1983
RX SEG ECONOPLUS
K833286 · EIS
Genesis Industries, Inc.
Dental · 67d
Cleared Nov 28, 1983
JH PEPTONE AGAR
K833291 · JSH
Acumedia Manufacturers, Inc.
Microbiology · 67d
Cleared Nov 28, 1983
VECTOR SEIGE 2023645 AC POWERED STIMU-
K833305 · LIH
Metronex Engineering
Neurology · 66d
Cleared Nov 28, 1983
BETATRON I AMBULATORY INSULIN PUMP
K833306 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 66d
Cleared Nov 28, 1983
RESPIRONICS PR VALVE
K833327 · BSK
Respironics, Inc.
Anesthesiology · 62d
Cleared Nov 28, 1983
VOLUREX II
K833337 · BWF
Dhd Medical Products Div. Diemolding...
Anesthesiology · 62d
Cleared Nov 28, 1983
AUTO-TENS MODEL VI DUAL CHANNEL BATT
K833354 · GZJ
Physio Tronics Corp.
Neurology · 61d
Cleared Nov 28, 1983
LINEAR VIBRATION A MCSHIRLEY PRODUCT
K833370 · IRO
Mcshirley Products, Inc.
Physical Medicine · 61d
Cleared Nov 28, 1983
TRI-MED 511 INFANT RESPIRATION MONITOR
K833397 · CCK
Tri-Med, Inc.
Anesthesiology · 59d
Cleared Nov 28, 1983
COMPUTERSCOPE CPS-ABR
K833413 · GWL
Rc Electronics, Inc.
Neurology · 59d
Cleared Nov 28, 1983
ENDOSCOPIC RETROGRADE
K833417 · ODD
Microvasive
Gastroenterology & Urology · 56d
Cleared Nov 28, 1983
SYRINGE,PISTON NEEDLE, HOLLOW LUMEN
K833460 · FMF
Aldrich Chemical Co., Inc.
General Hospital · 54d
Cleared Nov 28, 1983
FPC FECAL PARASITE CONCENTRATOR
K833469 · LKS
Evergreen Scientific, Inc.
Immunology · 53d
Cleared Nov 28, 1983
SONICOMP
K833488 · HEM
Sonicaid, Inc.
Obstetrics & Gynecology · 52d
Cleared Nov 28, 1983
CHEMONUCLEOLYSIS TABLE
K833509 · FWY
Stryker Corp.
General & Plastic Surgery · 48d
Cleared Nov 28, 1983
NEEDLE CATHETER JEJUNOSTOMY KIT
K833513 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 48d
Cleared Nov 28, 1983
SURGICAL INSTRUMENT
K833541 · GAD
Hirata Sangyo Co. USA, Inc.
General & Plastic Surgery · 62d
Cleared Nov 28, 1983
SURGICAL INSTRUMENT
K833542 · GEN
Hirata Sangyo Co. USA, Inc.
General & Plastic Surgery · 62d