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
145801–145824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 1985
PERIPHERAL NERVE STIMULATOR MODEL A400
K852962 · BXN
Fisher & Paykel Allied Products , Ltd.
Anesthesiology · 150d
Cleared Dec 09, 1985
CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90
K853072 · DYB
Camino Laboratories, Inc.
Cardiovascular · 139d
Cleared Dec 09, 1985
RT3600(115V) RT3600(220/240V)
K853249 · ITX
General Electric Co.
Radiology · 130d
Cleared Dec 09, 1985
MODEL 804 (TENS)
K853442 · GZJ
Oriental Medical Supplies, Inc.
Neurology · 115d
Cleared Dec 09, 1985
MILLAR/GALANTE PRECOATED TOTAL KNEE
K853661 · JWH
Zimmer, Inc.
Orthopedic · 97d
Cleared Dec 09, 1985
ATRIUM PLASMA TFE SYNTHETIC ARTERY
K853725 · DSY
Atrium Medical Corp.
Cardiovascular · 94d
Cleared Dec 09, 1985
LIFEPAK 8 MODIFICATION
K853732 · DRO
Physio-Control Corp.
Cardiovascular · 94d
Cleared Dec 09, 1985
NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000
K853791 · DTR
Norton Performance Plastics Corp.
Cardiovascular · 89d
Cleared Dec 09, 1985
NEURO PULSE II
K853836 · GZJ
Nagata Engineering Co.
Neurology · 83d
Cleared Dec 09, 1985
LIFE WATCH RESPIRATORY MONITOR
K853840 · CHL
The Perkin-Elmer Corp.
Chemistry · 84d
Cleared Dec 09, 1985
TITANIUIM BONE SCREW
K853869 · HWC
George Tiemann & Co.
Orthopedic · 83d
Cleared Dec 09, 1985
REGULATOR-INHALATOR SYSTEM
K853971 · BTL
Stephenson Industries, Inc.
Anesthesiology · 74d
Cleared Dec 09, 1985
POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD
K854069 · DTB
Intermedics, Inc.
Cardiovascular · 66d
Cleared Dec 09, 1985
SUPPORT ARM
K854162
Healthmate, Inc.
General & Plastic Surgery · 55d
Cleared Dec 09, 1985
MURPHY ADJUSTABLE SPLINT
K854270 · KQZ
Comfortex, Inc.
Orthopedic · 47d
Cleared Dec 09, 1985
TRICON UNICOMPARTMENTAL KNEE SYSTEM
K854325 · HSX
Richards Medical Co., Inc.
Orthopedic · 42d
Cleared Dec 09, 1985
KIRSCHNER INTRAMEDULLARY NAIL SYSTEM
K854338 · HSB
Kirschner Medical Corp.
Orthopedic · 42d
Cleared Dec 09, 1985
PULMO-AIDE MODEL 5610D
K854520 · CCQ
The Devilbiss Co.
Anesthesiology · 27d
Cleared Dec 09, 1985
KIRSCHNER SPINAL PRODUCT SYSTEM
K854524 · KWP
Kirschner Medical Corp.
Orthopedic · 27d
Cleared Dec 09, 1985
DISPOSABLE SYRINGES & NEEDLES
K854563 · FMF
Medelec Intl. Corp.
General Hospital · 25d
Cleared Dec 06, 1985
AMIZYME-CMV KIT
K842529 · GQI
Amico Lab, Inc.
Immunology · 526d
Cleared Dec 06, 1985
AMIZYME-EBV TEST KIT
K842530 · GNP
Amico Lab, Inc.
Immunology · 526d
Cleared Dec 06, 1985
AMIZYME-HSV TYPES 1 & 2 TEST KITS
K842531 · GQO
Amico Lab, Inc.
Immunology · 526d
Cleared Dec 06, 1985
ANTI-CYTOMEGALOVIRUS KIT
K842661 · GQI
Amico Lab, Inc.
Immunology · 514d