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
97657–97680 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 24, 1996
IMZ MEMBRANE TACK SYSTEM
K960945 · DZL
Interpore Intl.
Dental · 77d
Cleared May 24, 1996
BOSWORTH CH I
K961198 · EBG
Harry J. Bosworth Co.
Dental · 58d
Cleared May 24, 1996
LA POSITIVE CONTROL PLASMA
K961370 · GGC
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared May 24, 1996
GC FUJI ORTHO
K961417 · DYH
GC America, Inc.
Dental · 42d
Cleared May 24, 1996
FUJI II LC (IMPROVED)
K961584 · EMA
GC America, Inc.
Dental · 30d
Cleared May 23, 1996
RIBOSOMAL P EIA TEST SYSTEM
K950169 · MQA
Hogan & Hartson
Immunology · 492d
Cleared May 23, 1996
HANDMASTER NMS1
K952273 · IPF
Neuromusclar Electrical Stimulation...
Physical Medicine · 374d
Cleared May 23, 1996
VISUWELL REAGIN II
K952802 · GMQ
Biomira Diagnostics, Inc.
Microbiology · 339d
Cleared May 23, 1996
CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION)
K953205 · KOI
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 359d
Cleared May 23, 1996
PREMIER HSV PLUS
K953839 · LGC
Meridian Diagnostics, Inc.
Microbiology · 281d
Cleared May 23, 1996
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP
K955180 · FRN
Sims Deltec, Inc.
General Hospital · 192d
Cleared May 23, 1996
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY
K955449 · MID
American Laboratory Products Co., Ltd.
Immunology · 176d
Cleared May 23, 1996
BUHLMANN VITAMIN B6 REA
K955561 · CDD
American Laboratory Products Co., Ltd.
Chemistry · 169d
Cleared May 23, 1996
CPR D & C TRAY
K960239 · HHK
Custom Pack Reliability
Obstetrics & Gynecology · 128d
Cleared May 23, 1996
CPR C-SECTION DELIVERY PACK
K960243 · MLS
Custom Pack Reliability
Obstetrics & Gynecology · 128d
Cleared May 23, 1996
PRECLUDE IMA SLEEVE
K960532 · MFX
W.L. Gore & Associates, Inc.
Cardiovascular · 106d
Cleared May 23, 1996
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
K960755 · DQX
Medtronic Cardiac Surgery, Medtronic,...
Cardiovascular · 90d
Cleared May 23, 1996
MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR
K960777 · FRC
Mdt Corp., Inc.
General Hospital · 87d
Cleared May 23, 1996
CAROLINA NARROW FABRIC COMPANY OPEN TOE ANTI-EMBOLISM STOCKING
K960931 · DWL
Carolina Narrow Fabric Co.
General Hospital · 77d
Cleared May 23, 1996
AST INCORPORATING DST
K961114 · CIT
Trace Scientific , Ltd.
Chemistry · 64d
Cleared May 23, 1996
SUPRASSON P5 BOOSTER
K961158 · ELC
Satelec
Dental · 62d
Cleared May 23, 1996
MANAN INTRODUCER SHEALTH/NEEDLE
K961216 · FGE
Manan Medical Products, Inc.
Gastroenterology & Urology · 56d
Cleared May 22, 1996
SPERMICIDAL LUBRICATED CONDOM
K931220 · LTZ
Monsys USA, Inc.
Obstetrics & Gynecology · 1169d
Cleared May 22, 1996
LLC-MK2 (MONKEY KIDNEY, MACACA MULATA) CELL CULTURE
K951440 · KIR
Viromed Laboratories, Inc.
Pathology · 420d