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
75025–75048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 2002
DIGITAL CLINICAL THERMOMETER, MODELS ACT 2030, 2038
K021612 · FLL
Actherm, Inc.
General Hospital · 14d
Cleared May 30, 2002
DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
K021614 · FLL
Actherm, Inc.
General Hospital · 14d
Cleared May 29, 2002
MICRO-INDUCTION 1000 SYSTEM
K013615 · DPS
Harbinger Medical, Inc.
Cardiovascular · 205d
Cleared May 29, 2002
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162,...
K020646 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444
K021384 · DIF
Bio-Rad
Chemistry · 27d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463
K021411 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS...
K021414 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS...
K021415 · DIF
Bio-Rad
Chemistry · 26d
Cleared May 29, 2002
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR...
K021439 · LZG
Animas Corp.
General Hospital · 23d
Cleared May 29, 2002
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K021577 · GEI
Neothermia Corp.
General & Plastic Surgery · 15d
Cleared May 28, 2002
ACCESS CARDIOSYSTEMS MANUAL DEFIBRILLATOR
K011461 · LDD
Access Cardiosystems, Inc.
Cardiovascular · 379d
Cleared May 28, 2002
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
K013687 · LRK
Steven K. Sue
Dental · 202d
Cleared May 28, 2002
SELECT STIM
K020637 · IPF
Care Rehab and Orthopaedic
Physical Medicine · 90d
Cleared May 28, 2002
KSEA SCB MEDIA CONTROL
K020640 · FTA
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 90d
Cleared May 28, 2002
EZ-SCOPE AN & EZ-SCOPE AN LITE
K020643 · IYX
Health Policy Resorters Group, LLC
Radiology · 90d
Cleared May 28, 2002
TSRH SPINAL SYSTEM
K020699 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 88d
Cleared May 28, 2002
PADPRO, MODEL 2502
K020743 · MKJ
Padpro, LLC
Cardiovascular · 83d
Cleared May 28, 2002
GYRUS ENT SOMNOPLASTY TISSUE COAGULATING ELECTRODE, MODEL 2420
K020778 · GEI
Gyrus Ent LLC
General & Plastic Surgery · 78d
Cleared May 28, 2002
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K020893 · LRK
Dennis R. Bailey, Dds
Dental · 70d
Cleared May 28, 2002
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744,...
K021118 · GXZ
Class A Ent.
Neurology · 50d
Cleared May 28, 2002
AROMACRYL
K021121 · EBI
Aromacryl, LLC
Dental · 50d
Cleared May 28, 2002
OSS LES PROXIMAL FEMORAL COMPONENT
K021380 · JDI
Biomet, Inc.
Orthopedic · 27d
Cleared May 24, 2002
14F X 55CM ASH SPLIT-CATH XL, MODEL ASPC55-XL
K020315 · MSD
Medcomp
Gastroenterology & Urology · 115d
Cleared May 24, 2002
IRRIGATING CANNULA
K020614 · OCX
Ca Guard, Ltd.
Gastroenterology & Urology · 88d