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
7177–7200 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2024
TRIBRID® Unicompartmental Knee System
K232114 · HSX
Kyocera Medical Technologies, Inc.
Orthopedic · 265d
Cleared Apr 04, 2024
Reprocessed VersaCross Steerable Sheath
K232037 · PNE
Innovative Health, LLC
Cardiovascular · 269d
Cleared Apr 04, 2024
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
K232027 · GKA
Sebia
Hematology · 272d
Cleared Apr 04, 2024
VSP PEEK Cranial Implant
K231834 · GWO
3D Systems, Inc.
Neurology · 287d
Cleared Apr 03, 2024
Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
K240618 · HQD
Acuity Polymers, Inc.
Ophthalmic · 29d
Cleared Apr 03, 2024
AnyPlus II Spinal Fixation System
K240350 · NKB
GS Medical Co., Ltd.
Orthopedic · 58d
Cleared Apr 03, 2024
IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506,...
K240282 · OHT
Dongguan Boyuan Intelligent...
General & Plastic Surgery · 62d
Cleared Apr 03, 2024
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
K240135 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 76d
Cleared Apr 03, 2024
Oxevision Sleep Device
K233618 · LEL
Oxehealth Limited
Neurology · 142d
Cleared Apr 03, 2024
Uresta®
K233548 · HHW
Resilia, Inc.
Gastroenterology & Urology · 152d
Cleared Apr 03, 2024
AI-Rad Companion Organs RT
K232899 · QKB
Siemens Medical Solutions U.S.A.
Radiology · 198d
Cleared Apr 03, 2024
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
K232653 · NXC
Blue Sky Bio, LLC
Dental · 216d
Cleared Apr 03, 2024
Digital Thermometer
K230889 · FLL
Wenzhou Yosun Medical Technology Co.,Ltd
General Hospital · 369d
Cleared Apr 02, 2024
Calibra Abutment Resin Cement
K240888 · EMA
Dentsply Sirona
Dental · 1d
Cleared Apr 02, 2024
SnapshotNIR model KD205
K240601 · MUD
Kent Imaging, Inc.
General & Plastic Surgery · 29d
Cleared Apr 02, 2024
Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy...
K240080 · LZA
Syntex Healthcare Products Co., Ltd.
General Hospital · 82d
Cleared Apr 02, 2024
Zoom 6F Insert Catheters
K233975 · DQO
Imperative Care, Inc.
Cardiovascular · 109d
Cleared Apr 02, 2024
ECG-less Cardiac
K233750 · JAK
Ge Medical Systems, LLC
Radiology · 132d
Cleared Apr 02, 2024
Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System
K232835 · JAK
Canon Medical Systems Corporation
Radiology · 201d
Cleared Apr 02, 2024
R&G Surgical Mask
K232112 · FXX
R&G Seguridad E Higiene Industrial...
General Hospital · 263d
Cleared Apr 02, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
K211815 · SAN
Affinity Biosensors
Microbiology · 1026d
Cleared Apr 01, 2024
ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag,...
K240635 · GCJ
Ximedica
General & Plastic Surgery · 26d
Cleared Apr 01, 2024
MagnetOs Putty
K240442 · MQV
Kuros Biosciences B.V
Orthopedic · 47d
Cleared Apr 01, 2024
AlphaVac MMA F1885 System (H787253020)
K240397 · QEZ
AngioDynamics, Inc.
Cardiovascular · 52d