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

139 results for "Mcra, LLC"
97–120 of 139
Search insights Median review: 118d Cleared: 100% Top manufacturer: Implantcast GmbH Lead specialty: Orthopedic
Cleared Mar 28, 2022
OSSIOfiber Suture Anchor
K213415 · MAI
OSSIO , Ltd.
Orthopedic · 160d
Cleared Mar 23, 2022
ArthroFree Wireless Surgical Camera System
K213860 · GCJ
Lazurite Holdings, LLC
General & Plastic Surgery · 103d
Cleared Jan 21, 2022
OSSIOfiber® Staple
K212594 · MNU
OSSIO , Ltd.
Orthopedic · 158d
Cleared Jan 14, 2022
BRM TOOL Screws
K203773 · HWC
Brm Extremities Srl
Orthopedic · 387d
Cleared Jan 10, 2022
MagnetOs granules
K213111 · MQV
Kuros Biosciences B.V
Orthopedic · 108d
Cleared Dec 21, 2021
OSSIOfiber Compression Screw, 3.5mm
K213596 · HWC
OSSIO , Ltd.
Orthopedic · 39d
Cleared Aug 20, 2021
Simplify Disc
K211757 · QLQ
Nuvasive, Inc.
Orthopedic · 74d
Cleared Jul 23, 2021
Klassic Knee System
K211602 · JWH
Total Joint Orthopedics, Inc.
Orthopedic · 60d
Cleared Jul 20, 2021
LifeLens Wireless ECG Monitor
K203168 · DSH
LifeLens Technologies, Inc.
Cardiovascular · 270d
Cleared Jul 19, 2021
Elos® Intramedullary Nailing System
K201147 · HSB
Intrauma S.P.A
Orthopedic · 446d
Cleared Jul 08, 2021
BioWave BioWraps
K203158 · GXY
Biowave Corporation
Neurology · 259d
Cleared Jun 07, 2021
SnugKap
K193383 · MVA
Headstart, Ltd.
Neurology · 550d
Cleared Feb 26, 2021
Cuptimize
K203651 · LLZ
Cuptimize, Inc.
Radiology · 74d
Cleared Feb 24, 2021
BioWaveGO RX
K210202 · GZJ
Biowave Corporation
Neurology · 30d
Cleared Feb 03, 2021
EcoFit® Hip System
K203420 · LZO
Implantcast GmbH
Orthopedic · 76d
Cleared Feb 02, 2021
BioPoly Great Toe Hemiarthroplasty Implant
K203634 · KWD
BioPoly, LLC
Orthopedic · 53d
Cleared Jan 08, 2021
ACS LD Uni FB Knee System
K203341 · HSX
Implantcast GmbH
Orthopedic · 57d
Cleared Jan 06, 2021
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation...
K203465 · HTY
OSSIO , Ltd.
Orthopedic · 43d
Cleared Oct 27, 2020
IlluminOss Bone Stabilization System
K202887 · QAD
Illuminoss Medical, Inc.
Orthopedic · 29d
Cleared Oct 21, 2020
Trivergent Spinal Fixation System
K201427 · NKB
Benvenue Medical, Inc.
Orthopedic · 145d
Cleared Oct 16, 2020
MUTARS Cemented Femoral Stems
K200045 · MEH
Implantcast GmbH
Orthopedic · 282d
Cleared Oct 15, 2020
icotec Anterior Cervical Plate System
K201587 · KWQ
Icotec AG
Orthopedic · 126d
Cleared Oct 07, 2020
Fortilink Cages with TiPlus Technology
K201453 · MAX
Paradigm Spine GmbH
Orthopedic · 128d
Cleared Aug 13, 2020
IlluminOss Photodynamic Bone Stabilization System
K201961 · QAD
Illuminoss Medical, Inc.
Orthopedic · 30d