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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
95953–95976 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 22, 1996
ACTION POTENTIAL SIMULATION THERAPY DEVICE
K955470 · GZJ
Neurotech, Inc.
Neurology · 327d
Cleared Oct 22, 1996
CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
K962426 · JOZ
Chrono-Log Corp.
Hematology · 120d
Cleared Oct 22, 1996
ISOLA TWISTER CONNECTOR
K962645 · MNH
Acromed Corp.
Orthopedic · 106d
Cleared Oct 22, 1996
SALTERLABS 8660 SERIES NEBULIZER
K962879 · CAF
Salter Labs
Anesthesiology · 90d
Cleared Oct 22, 1996
KSEA CULDOCENTESIS SET
K962881 · HEW
Karl Storz Endoscopy
Obstetrics & Gynecology · 90d
Cleared Oct 22, 1996
OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
K963333 · HKI
Karl Storz Imaging, Inc.
Ophthalmic · 60d
Cleared Oct 21, 1996
TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE
K952083 · CAD
Clover Medical Equipment Services, Inc.
Anesthesiology · 537d
Cleared Oct 21, 1996
MERCURY MEDICAL EXPIRATORY RESISTANCE EXERCISER, RESISTEX
K954492 · BWF
Mercury Medical
Anesthesiology · 390d
Cleared Oct 21, 1996
DPS 4 DIALYZER PREPARATION SYSTEM
K955299 · LIF
Seratronics, Inc.
Gastroenterology & Urology · 336d
Cleared Oct 21, 1996
BALLOON CANNULA 15MM X 35MM,15MM X 55MM, 10/12MM X 55MM,10/12MM X 35MM,5MM X...
K960810 · HET
Marlo Surgical Technology
Obstetrics & Gynecology · 236d
Cleared Oct 21, 1996
PULSE DOSE SERIES
K961126 · NFB
Devilbiss Health Care, Inc.
Anesthesiology · 214d
Cleared Oct 21, 1996
CARROLL HEALTHCARE DLX 2300-111 ELECTRIC BED
K962250 · FNL
Carroll Healthcare, Inc.
General Hospital · 131d
Cleared Oct 21, 1996
BARD EAGLE INFLATION DEVICE
K962611 · KOE
Ryder Intl. Corp.
Gastroenterology & Urology · 110d
Cleared Oct 21, 1996
RENTON SUCTION DEVICE U.S. PATENT*4,767,404
K962920 · GCX
R&S Surgical, LLC
General Hospital · 87d
Cleared Oct 21, 1996
SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
K962931 · JKA
Smiths Industries Medical Systems, Inc.
Chemistry · 84d
Cleared Oct 21, 1996
GENXCATHETER
K963031 · MFD
Intl., Inc.
Obstetrics & Gynecology · 77d
Cleared Oct 21, 1996
STAPLE REMOVAL KIT
K963234 · GDT
Continental Medical Laboratories, Inc.
General & Plastic Surgery · 63d
Cleared Oct 21, 1996
UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH
K963338 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 59d
Cleared Oct 18, 1996
ISOLAB'S T4 TEST KIT
K951014 · KLI
Isolab, Inc.
Chemistry · 592d
Cleared Oct 18, 1996
GEON ELECTRONIC THERMOMETER
K952001 · FLL
Geon Corp.
General Hospital · 539d
Cleared Oct 18, 1996
TRUST
K954994 · GMQ
Guardian Scientific, Corp.
Microbiology · 353d
Cleared Oct 18, 1996
MICRO HAEMATOCRIT CENTRIFUGE
K960491 · CKG
Hawksley & Sons , Ltd.
Hematology · 260d
Cleared Oct 18, 1996
DISPOSABLE GAS SAMPLING INTERFACE KITS
K960972 · CCK
Marquest Medical Products, Inc.
Anesthesiology · 221d
Cleared Oct 18, 1996
ABBOTT CELL-DYN 4000 SYSTEM
K961439 · GKZ
Abbott Diagnostics
Hematology · 186d