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
126073–126096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1990
HERAEUS LASERSONICS CO2 WAVEGUIDE DELIVERY SYSTEM
K900751 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 69d
Cleared May 03, 1990
MEDICAM ARTHROSCOPE SYSTEMS
K900812 · HRX
Kirschner Medical Corp.
Orthopedic · 71d
Cleared May 03, 1990
KOPANS HOOKWIRE LESION LOCALIZATION NEEDLE
K900903 · GDF
Milex Products, Inc.
General & Plastic Surgery · 65d
Cleared May 03, 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984 · DTB
Medtronic Vascular
Cardiovascular · 63d
Cleared May 03, 1990
HEXASCAN HANDPIECE
K901008 · GEX
Lihtan Technologies, Inc.
General & Plastic Surgery · 59d
Cleared May 03, 1990
CHILDREN'S SUNGLASSES
K901468 · HQY
M. & S. Shillman, Inc.
Ophthalmic · 35d
Cleared May 03, 1990
FORTRESS COMMUTER FT (FOLDING TRANSPORT)
K901707 · ITI
Fortress, Inc.
Physical Medicine · 20d
Cleared May 03, 1990
INSTANT ICE PACK
K901834 · IMD
Impact Packaging Corp.
Physical Medicine · 9d
Cleared May 03, 1990
COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2
K901859 · JHR
Diagnostic Products Corp.
Immunology · 9d
Cleared May 02, 1990
FRENTA(R) DUO-SET
K895246 · KNT
Delmed, Inc.
Gastroenterology & Urology · 254d
Cleared May 02, 1990
600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA
K895330 · KNT
Delmed, Inc.
Gastroenterology & Urology · 244d
Cleared May 02, 1990
ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE
K895366 · KNT
Fresenius USA, Inc.
Gastroenterology & Urology · 247d
Cleared May 02, 1990
ENTERAL PUMP SET W/ENTERAL SPIKE FOR USE W/FEED PU
K895696 · KNT
Delmed, Inc.
Gastroenterology & Urology · 223d
Cleared May 02, 1990
ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III
K895919 · KNT
Delmed, Inc.
Gastroenterology & Urology · 204d
Cleared May 02, 1990
ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III
K895933 · KNT
Delmed, Inc.
Gastroenterology & Urology · 204d
Cleared May 02, 1990
MD2 PERSONAL INFUSION SYSTEM
K896544 · FRN
Norfolk Medical Products, Inc.
General Hospital · 166d
Cleared May 02, 1990
URINE COLLECTOR LEG BAG
K896688 · KNX
Medline Industries, Inc.
Gastroenterology & Urology · 155d
Cleared May 02, 1990
DYNA-FLO URINARY DRAINAGE BAG
K896695 · EYZ
Medline Industries, Inc.
Gastroenterology & Urology · 155d
Cleared May 02, 1990
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K896853 · KWL
Howmedica Corp.
Orthopedic · 148d
Cleared May 02, 1990
ACCUPROBE MYCOBACTERIUM AVIUM COMPLEX CULTURE
K897078 · LQF
Gen-Probe, Inc.
Microbiology · 131d
Cleared May 02, 1990
OPERAND* LUBRICATING JELLY
K900110 · KMJ
General Medical Co.
General Hospital · 113d
Cleared May 02, 1990
LYME IGM ELISA TEST SYSTEM
K900196 · LSR
Zeus Scientific, Inc.
Microbiology · 106d
Cleared May 02, 1990
ENZYMUN TEST(R) CORTISOL
K900485 · CGR
Boehringer Mannheim Corp.
Chemistry · 90d
Cleared May 02, 1990
INTERSON MULTIPLANE RECTAL PROBE FOR ALOKA ULTRA.
K900555 · ITX
Interson Corp.
Radiology · 85d