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
22105–22128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 27, 2019
SwimCount Sperm Quality Test
K183602 · POV
Motilitycount Aps
Hematology · 183d
Cleared Jun 27, 2019
LiverMultiScan (LMSv3)
K190017 · LNH
Perspectum Diagnostics, Ltd.
Radiology · 175d
Cleared Jun 27, 2019
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs...
K190080 · LZA
Comfort Rubber Gloves Industries Sdn....
General Hospital · 162d
Cleared Jun 27, 2019
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition...
K190578 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Jun 27, 2019
DynaFlex
K190583 · NXC
Dyna Flex
Dental · 113d
Cleared Jun 27, 2019
FlexGard Cut-Resistant Glove Liners
K190782 · KGO
Ldi Corporation
General Hospital · 92d
Cleared Jun 27, 2019
ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System
K191175 · OBJ
Acist Medical Systems, Inc.
Cardiovascular · 57d
Cleared Jun 27, 2019
ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector
K191438 · OCX
Erbe USA, Inc.
Gastroenterology & Urology · 28d
Cleared Jun 27, 2019
Human IgM Kit for use on SPAPlus
K191465 · CFN
The Binding Site Group , Ltd.
Immunology · 24d
Cleared Jun 26, 2019
Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set
K182832 · KGC
Cook Incorporated
Gastroenterology & Urology · 260d
Cleared Jun 26, 2019
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with...
K182851 · LZA
O&M Halyard, Inc.
General Hospital · 259d
Cleared Jun 26, 2019
R2GATE
K190096 · LLZ
Megagen Implant Co., Ltd.
Radiology · 155d
Cleared Jun 26, 2019
Straumann CARES Screw-Retained Bridges and Bars
K190097 · NHA
Institut Straumann AG
Dental · 155d
Cleared Jun 26, 2019
Elos Accurate® Customized Abutment
K190299 · NHA
Elos Medtech Pinol A/S
Dental · 135d