FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
154873–154896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 28, 1983
PDI SURGICAL SCRUB/BRUSH T150-70
K833549 · NAB
Nice-Pak Products, Inc.
General & Plastic Surgery · 88d
Cleared Nov 28, 1983
HOT/ICE DISPOSABLE BLANKET
K833564 · ILO
Thermo Temp, Inc.
Physical Medicine · 47d
Cleared Nov 28, 1983
FEEDING TUBE
K833591 · KNT
Medovations, Inc.
Gastroenterology & Urology · 47d
Cleared Nov 28, 1983
ENTRI FLEX FEEDING TUBE
K833621 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 45d
Cleared Nov 28, 1983
SHUTT UNIVERSAL STRESS POST
K833624 · FWZ
Concept, Inc.
General & Plastic Surgery · 45d
Cleared Nov 28, 1983
ACTIVE LIFE
K833625 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 45d