FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
43225–43248 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2012
ECHELON 60 ENDOSCPIC LINEAR CUTTER RELOAD, WHITE
K121600 · GDW
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 45d
Cleared Jul 16, 2012
OSTOMY IRRIGATION SET
K121833 · EXD
Coloplast A/S
Gastroenterology & Urology · 24d
Cleared Jul 16, 2012
NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
K121837 · KWQ
Nuvasive, Inc.
Orthopedic · 24d
Cleared Jul 13, 2012
LSI SOLUTIONS FORNISEE SYSTEM UTERINE MANIPULATOR AND ACCESSORIES
K111014 · HEW
Lsi Solutions, Inc.
Obstetrics & Gynecology · 459d
Cleared Jul 13, 2012
MONICA AN24
K112390 · OSP
Monica Healthcare, Ltd.
Obstetrics & Gynecology · 330d
Cleared Jul 13, 2012
RI MSC (MIGRATION SEDIMENTATION CHAMBER)
K112413 · MQK
Research Instruments , Ltd.
Obstetrics & Gynecology · 326d
Cleared Jul 13, 2012
CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR
K112840 · CCK
Seebreath AB
Anesthesiology · 288d
Cleared Jul 13, 2012
HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM
K113192 · NBW
Infopia Co, Ltd.
Chemistry · 256d
Cleared Jul 13, 2012
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT...
K113374 · CIX
Alfa Wassermann Diagnostic...
Chemistry · 240d
Cleared Jul 13, 2012
PLANCET
K113513 · FMK
Micropoint Technologies Pte, Ltd.
General & Plastic Surgery · 228d
Cleared Jul 13, 2012
FLEXITIME MONOPHASE PRO SCAN
K113574 · ELW
Heraeus Kulzer, LLC
Dental · 224d
Cleared Jul 13, 2012
CRUX VENA CAVA FILTER SYSTEM
K120402 · DTK
Crux Biomedical
Cardiovascular · 156d
Cleared Jul 13, 2012
SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
K120413 · OCC
Focus Diagnostics, Inc.
Microbiology · 154d
Cleared Jul 13, 2012
LIL-LETS SILK COMFORT COMPACT, PLASTIC APPLICATOR, LITE, REGULAR, SUPER,...
K120481 · HEB
Tosama, D.O.O.
Obstetrics & Gynecology · 148d
Cleared Jul 13, 2012
QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE)
K120827 · NEW
Angiotech
General & Plastic Surgery · 116d
Cleared Jul 13, 2012
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
K120903 · HRS
Acumed, LLC
Orthopedic · 109d
Cleared Jul 13, 2012
CAPNOGRAPHY PAD (92516)
K121017 · CCK
Spacelabs Healthcare
Anesthesiology · 100d
Cleared Jul 13, 2012
EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
K121161 · KPE
Acta Medical, LLC
General Hospital · 87d
Cleared Jul 13, 2012
RESIN 11
K121170 · BYI
Respinnovation Sas
Anesthesiology · 87d
Cleared Jul 13, 2012
INFILL INTERVERTEBRAL BODY FUSION DEVICE
K121733 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 30d
Cleared Jul 13, 2012
MANTARAY GUIDEWIRES
K121745 · DQX
Bridgepoint Medical
Cardiovascular · 29d
Cleared Jul 13, 2012
CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
K121767 · OCL
Medtronic, Inc.
Cardiovascular · 28d
Cleared Jul 12, 2012
CS1000 LIGHT THERAPY DEVICE
K110558 · ILY
Genesis Health Light Corporation
Physical Medicine · 500d
Cleared Jul 12, 2012
ARROW REVERSE SHOULDER SYSTEM
K112193 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 349d