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
13057–13080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2022
FairFix AM Adjustable Button FairFix PSP Adjustable Button
K221389 · MBI
Medacta International S.A.
Orthopedic · 26d
Cleared Jun 07, 2022
Infinity Gateway Suite
K203579 · MSX
Draeger Medical Systems, Inc.
Cardiovascular · 547d
Cleared Jun 07, 2022
Adhese Universal DC, Cention Primer
K210804 · KLE
Ivoclar Vivadent, AG
Dental · 447d
Cleared Jun 07, 2022
Natural Rubber Latex Ultrasound Transducer Probe Covers
K213087 · ITX
Global Protection Corp.
Radiology · 256d
Cleared Jun 07, 2022
FX V135 Shoulder Prosthesis
K213117 · PHX
Fx Shoulder USA, Inc.
Orthopedic · 253d
Cleared Jun 07, 2022
Lap-Band System Calibration Tube
K220455 · KNT
Reshape Lifesciences
Gastroenterology & Urology · 110d
Cleared Jun 07, 2022
Zoupure Nitrile Powder Free Examination glove
K220693 · LZA
Thai Rayong Product Glove Zoupure...
General Hospital · 90d
Cleared Jun 07, 2022
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
K221160 · PQA
Cepheid
Microbiology · 47d
Cleared Jun 07, 2022
D²RS and D²RS 9090
K221335 · OWB
Stephanix
Radiology · 29d
Cleared Jun 07, 2022
WHILL Model F
K221438 · ITI
Whill, Inc.
Physical Medicine · 21d
Cleared Jun 06, 2022
Diacare 7000
K211207 · PBX
Globus Sport and Health Technologies,...
General & Plastic Surgery · 410d
Cleared Jun 06, 2022
Keos Anterior Cervical Interbody Fusion Device System
K212450 · ODP
Keos
Orthopedic · 305d
Cleared Jun 06, 2022
Disposable Polypectomy Snare
K213222 · FDI
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 250d
Cleared Jun 06, 2022
Multi-Band Ligator
K213223 · FHN
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 250d
Cleared Jun 06, 2022
Powder Free Nitrile Gloves
K213448 · LZA
St Future International Limited
General Hospital · 224d
Cleared Jun 06, 2022
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K220358 · IYN
GE Medical Systems Ultrasound and...
Radiology · 118d
Cleared Jun 06, 2022
PrimeLOC Attachment System
K220612 · NHA
Innovative Product Brands, Inc.
Dental · 95d
Cleared Jun 06, 2022
Arthrex Knotless AC Repair Devices
K220947 · HTN
Arthrex, Inc.
Orthopedic · 66d
Cleared Jun 06, 2022
Surgical Face Mask (HNFM0304)
K221222 · FXX
Shanghai Hua EN Industrial Co, Ltd.
General Hospital · 40d
Cleared Jun 06, 2022
Drug Relief v1
K221231 · PZR
Dyansys, Inc.
Neurology · 38d
Cleared Jun 06, 2022
Smart Correction System Rings and Compatible HA-Coated Half Pins
K221366 · KTT
Wishbone Medical, Inc.
Orthopedic · 25d
Cleared Jun 05, 2022
Q2 Blood Administration Sets
K213846 · FPA
Quest Medical, Inc.
General Hospital · 177d
Cleared Jun 03, 2022
SILKRO
K210084 · GEI
Hironic Co., Ltd.
General & Plastic Surgery · 507d
Cleared Jun 03, 2022
Portable Oxygen Concentrator, model: P2-E6
K210371 · CAW
Qingdao Kingon Medical Science and...
Anesthesiology · 480d