FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
22681–22704 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 2019
LIGHTMED Ultrasound System
K183173 · IYO
Lightmed USA, Inc.
Radiology · 227d
Cleared Jul 01, 2019
TriMed Nitinol Staple System
K190166 · JDR
TriMed, Inc.
Orthopedic · 151d
Cleared Jul 01, 2019
MRopen 0.5 T
K190524 · LNH
Asg Superconductors S.P.A.
Radiology · 119d
Cleared Jul 01, 2019
IKON 40 Manual Wheelchair
K190550 · IOR
Broda Seating (Broda Lp)
Physical Medicine · 118d
Cleared Jul 01, 2019
BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)
K190905 · LON
Becton, Dickinson and Company
Microbiology · 84d
Cleared Jul 01, 2019
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K190980 · DRF
Innovative Health, LLC
Cardiovascular · 77d
Cleared Jun 28, 2019
SureTouch Mobile Pressure Mapping System
K181672 · NKA
Sure, Inc.
Obstetrics & Gynecology · 368d
Cleared Jun 28, 2019
ClearEndoclip
K183021 · PKL
Finemedix Co., Ltd.
Gastroenterology & Urology · 239d
Cleared Jun 28, 2019
TxTi IBF System
K183064 · MAX
Innovasis, Inc.
Orthopedic · 235d
Cleared Jun 28, 2019
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical...
K183389 · KGO
Hartalega NGC Sdn. Bhd.
General Hospital · 204d
Cleared Jun 28, 2019
UltraFlex IAB
K190101 · DSP
Arrow International, Inc.
Cardiovascular · 157d
Cleared Jun 28, 2019
RecoveryRx
K190251 · ILX
Bioelectronics Corporation
Physical Medicine · 141d
Cleared Jun 28, 2019
iC-GN iC-Cassette for use on the iC-System
K190341 · PEN
Icubate, Inc.
Microbiology · 134d
Cleared Jun 28, 2019
Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3,...
K190475 · DQY
Centerpoint Systems
Cardiovascular · 121d
Cleared Jun 28, 2019
MicroLink All-Suture Button Fixation System (Radiolucent)
K190516 · HTN
Conmed Corporation
Orthopedic · 116d
Cleared Jun 28, 2019
MicroLink All-Suture Button Fixation System (Radiopaque)
K190582 · HTN
Conmed Corporation
Orthopedic · 114d
Cleared Jun 28, 2019
Straumann CI RD Ceramic Healing Caps
K190654 · NHA
Institut Straumann AG
Dental · 106d
Cleared Jun 28, 2019
Stryker Surgeon iD Mandible Recon Plate
K190696 · JEY
Stryker
Dental · 102d
Cleared Jun 28, 2019
NAVIO
K191223 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 52d
Cleared Jun 28, 2019
Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program...
K191450 · QBJ
Dexcom, Inc.
Chemistry · 28d
Cleared Jun 28, 2019
HEALIX ADVANCE Anchor with DYNA+TAPE Sutures
K191483 · MBI
Medos International SARL
Orthopedic · 24d
Cleared Jun 27, 2019
Z-Robot Patient Positioning System
K182683 · JAI
Chinan Biomedical Technology, Inc.
Radiology · 274d
Cleared Jun 27, 2019
Rochal Bioshield Silicone Film
K182733 · KMF
Rochal Industries, LLC
General & Plastic Surgery · 272d
Cleared Jun 27, 2019
VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II...
K183183 · GAM
Ethicon, Inc.
General & Plastic Surgery · 220d