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
84025–84048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 08, 1999
ISOBAR SPINAL SYSTEM
K992738 · MNI
Encore Orthopedics, Inc.
Orthopedic · 87d
Cleared Nov 08, 1999
LORENZ SMALL FRAGMENT SYSTEM
K992961 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 67d
Cleared Nov 08, 1999
DIGIT WIDGET
K992970 · JDW
Hand Biomechanics Lab, Inc.
Orthopedic · 66d
Cleared Nov 08, 1999
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
K993141 · LCX
Phamatech
Chemistry · 48d
Cleared Nov 08, 1999
DORNIER SCANNER HANDPIECE
K993146 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 49d
Cleared Nov 08, 1999
CASTLE SURGICAL LIGHT, MODEL 3000
K993242 · FSY
Getinge/Castle, Inc.
General & Plastic Surgery · 42d
Cleared Nov 08, 1999
HP M2600A VIRIDIA TELEMETRY SYSTEM
K993516 · DSI
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Nov 05, 1999
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL...
K990103 · DTZ
Sorin Biomedical, Inc.
Cardiovascular · 297d
Cleared Nov 05, 1999
DELSONIC 2000
K990546 · ELC
Sds Dental, Inc.
Dental · 256d
Cleared Nov 05, 1999
WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
K991344 · KXK
Worldwide Medical Technologies, LLC
Radiology · 200d
Cleared Nov 05, 1999
ULTRA-CBX
K991486 · DWZ
Medcanica, Inc.
Cardiovascular · 191d
Cleared Nov 05, 1999
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · DRF
C.R. Bard, Inc.
Cardiovascular · 113d
Cleared Nov 05, 1999
PLUG 'N VIEW 3D, VERSION 1.0
K992654 · LLZ
Voxar Limited
Radiology · 88d
Cleared Nov 05, 1999
DEPUY TOTAL ELBOW SYSTEM
K992656 · JDC
DePuy Orthopaedics, Inc.
Orthopedic · 88d
Cleared Nov 05, 1999
URF DIGITAL - OT
K992660 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Nov 05, 1999
SURGEON'S GLOVES PRE-POWDERED, MODELS 6.5, 7, 7.5, 8, 8.5
K992752 · KGO
Pt. Maja Agung Latexindo
General Hospital · 81d
Cleared Nov 05, 1999
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992797 · LYZ
Shijiazhuang Hongxiang Plastics...
General Hospital · 78d
Cleared Nov 05, 1999
ANTIBACTERIAL ADHESIVE BANDAGE
K992817 · FRO
William Feinstein & Associates, Inc.
General & Plastic Surgery · 77d
Cleared Nov 05, 1999
QTEXX, NON-CHLORINATED, POWDER FREE NITRILE EXAMINATION GLOVES, POLYMER-COATED
K992924 · LZA
Latexx Partners Bhd.
General Hospital · 67d
Cleared Nov 05, 1999
DAISY PROTECTED SCALP VEIN SET
K992999 · FPA
Diasol, Inc.
General Hospital · 59d
Cleared Nov 05, 1999
MODIFICATION TO MP-3 POWER BASE CHAIR
K993032 · ITI
Merits Health Products., Inc.
Physical Medicine · 87d
Cleared Nov 05, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K993187 · FPA
Diasol, Inc.
General Hospital · 43d
Cleared Nov 05, 1999
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED
K993221 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 39d
Cleared Nov 05, 1999
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE
K993222 · LYY
Innovative Gloves Co;, Ltd.
General Hospital · 39d