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
16585–16608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2021
Resection Electrodes with HF cable
K210651 · FAS
Olympus Winter & Ibe GmbH
Obstetrics & Gynecology · 152d
Cleared Aug 03, 2021
ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content...
K210724 · KGO
Careplus (M) Sdn Bhd
General Hospital · 146d
Cleared Aug 03, 2021
Minitube Dentasleeve Protective Barrier Sleeves
K211026 · PEM
Minitube AB
Dental · 119d
Cleared Aug 03, 2021
Cannulated Fasteners and Nuts
K211290 · HWC
OsteoCentric Technologies
Orthopedic · 97d
Cleared Aug 03, 2021
Polychloroprene Powder Free Examination Glove Tested for Use with...
K211758 · OPC
Hartalega NGC Sdn. Bhd.
General Hospital · 57d
Cleared Aug 03, 2021
Venclose digiRF Generator with Maven Catheter, Venclose Maven System,...
K211806 · GEI
Venclose, Inc.
General & Plastic Surgery · 53d
Cleared Aug 03, 2021
Surgical Face Mask
K211897 · FXX
Zhejiang Hongyu Medicali Commodity...
General Hospital · 43d
Cleared Aug 03, 2021
Remex KA6
K212144 · IZL
Remedi Co., Ltd.
Radiology · 25d
Cleared Aug 02, 2021
OPTI® B-Lac Cassette
K200986 · CHL
Opti Medical Systems, Inc.
Chemistry · 474d
Cleared Aug 02, 2021
Disposable Medical Mask
K203174 · FXX
Dong Guan Kinyet Metal Products Co.,...
General Hospital · 280d
Cleared Aug 02, 2021
SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)
K203538 · KGO
Medline Industries, Inc.
General Hospital · 242d
Cleared Aug 02, 2021
Neodent Implant System - Mini Abutment 60°
K203542 · NHA
Jjgc Industria E Comercio DE...
Dental · 242d
Cleared Aug 02, 2021
Bullfrog Micro-Infusion Device
K210339 · KRA
Mercator Medsystems, Inc.
Cardiovascular · 178d
Cleared Aug 02, 2021
DEXA-C Cervical Interbody System
K210521 · ODP
Aurora Spine, Inc.
Orthopedic · 160d
Cleared Aug 02, 2021
breastscape v1.0
K211431 · QIH
Olea Medical
Radiology · 87d
Cleared Aug 02, 2021
Relivion
K212106 · PCC
Neurolief , Ltd.
Neurology · 27d
Cleared Aug 02, 2021
DynaCAD
K212175 · LLZ
Invivo Corporation
Radiology · 21d
Cleared Aug 01, 2021
H2H Powder Free Examination Blue Glove
K211182 · LZA
Ntl Innovation Co., Ltd.
General Hospital · 103d
Cleared Jul 30, 2021
Mini PCNL-System
K200770 · FED
Trokamed GmbH
Gastroenterology & Urology · 492d
Cleared Jul 30, 2021
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K201761 · QLG
Abbott Diabetes Care, Inc.
Chemistry · 396d
Cleared Jul 30, 2021
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208 · KKX
Avery Dennison Belgie Bvba
General Hospital · 358d
Cleared Jul 30, 2021
Sectum
K202780 · PBX
Neauvia North America
General & Plastic Surgery · 311d
Cleared CT Jul 30, 2021
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
K203224 · QAQ
Edwards Lifesciences, LLC
Cardiovascular · 270d
Cleared Jul 30, 2021
Summit Patella Plating System
K203408 · HRS
Endeavor Orthopaedics, LLC
Orthopedic · 253d