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
97273–97296 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1996
ULTRACUT 2000
K960374 · LFL
Ultralase Technologies, Inc.
General & Plastic Surgery · 154d
Cleared Jun 28, 1996
ACCUSIGN DOA 3,ACCUSIGN DOA, ACCUSIGN BAR/BZO/MTD, BIOSIGN DOA 3, BIOSIGN...
K961010 · DIS
Princeton BioMeditech Corp.
Toxicology · 107d
Cleared Jun 28, 1996
MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1
K961238 · LNH
Toshiba America Mri, Inc.
Radiology · 88d
Cleared Jun 28, 1996
BAGRIGHT RESPOSABLE CHILD RESUSCITATOR
K961331 · BTM
Medical Marketing Concepts
Anesthesiology · 81d
Cleared Jun 28, 1996
BAGRIGHT RESPOSABLE INFANT RESUSCITATOR
K961332 · BTM
Medical Marketing Concepts
Anesthesiology · 81d
Cleared Jun 28, 1996
GEM PREMIER PLUS MODEL 5500
K961335 · CHL
Mallinckrodt Sensor Systems, Inc.
Chemistry · 81d
Cleared Jun 28, 1996
SYNTHES MINI EXTERNAL FIXATOR
K961350 · KTT
Synthes (Usa)
Orthopedic · 84d
Cleared Jun 28, 1996
BAGRIGHT RESPOSABLE RESUSCITATOR
K961369 · BTM
Medical Marketing Concepts
Anesthesiology · 80d
Cleared Jun 28, 1996
EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS
K961433 · KTT
Electro-Biology, Inc.
Orthopedic · 74d
Cleared Jun 28, 1996
R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM
K961496 · HRS
Howmedica, Inc.
Orthopedic · 71d
Cleared Jun 28, 1996
PROFYLE TITANIUM HAND AND SMALL FRAGMENT SYSTEM
K961497 · HRS
Howmedica, Inc.
Orthopedic · 71d
Cleared Jun 28, 1996
HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER
K961511 · LZK
Lifecore Biomedical, Inc.
General & Plastic Surgery · 70d
Cleared Jun 28, 1996
RESPOSABLE CHILD RESUSCITATOR
K961868 · BTM
Medical Marketing Concepts
Anesthesiology · 44d
Cleared Jun 28, 1996
RESPOSABLE INFANT RESUSCITATOR
K961882 · BTM
Medical Marketing Concepts
Anesthesiology · 44d
Cleared Jun 28, 1996
DSL ACTIVE I-HCG ELISA
K961911 · JHI
Diagnostic Systems Laboratories, Inc.
Chemistry · 42d
Cleared Jun 28, 1996
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
K961938 · GJS
Nova Biomedical Corp.
Hematology · 39d
Cleared Jun 28, 1996
Q-5000
K961971 · FSS
Stryker Endoscopy
General & Plastic Surgery · 39d
Cleared Jun 28, 1996
STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416)
K962234 · EFQ
Howard Medical Co.
General & Plastic Surgery · 17d
Cleared Jun 27, 1996
BONESOURCE HYDROXYAPATITE CEMENT (HAC)
K953339 · GXP
Osteogenics, Inc.
Neurology · 346d
Cleared Jun 27, 1996
COMFIT
K953590 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 332d
Cleared Jun 27, 1996
PHILIPS EASYVISION
K953911 · LLZ
Philips Medical Systems, Inc.
Radiology · 311d
Cleared Jun 27, 1996
RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
K955495 · BTR
Rusch, Inc.
Anesthesiology · 209d
Cleared Jun 27, 1996
SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE
K955918 · LYY
Sinochem Ningbo Imp & Exp Corp.
General Hospital · 190d
Cleared Jun 27, 1996
INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KIT
K960173 · FAT
Gabriel Medical, Inc.
Gastroenterology & Urology · 163d