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
21985–22008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 25, 2019
SafeBreath Filter Mouthpiece
K190022 · CAH
MD Diagnostics Limited
General Hospital · 264d
Cleared Sep 25, 2019
Aloe Glide Lubricant
K190323 · NUC
Desert Harvest, Inc.
Obstetrics & Gynecology · 224d
Cleared Sep 25, 2019
Mediracer NCS
K190536 · JXE
Mediracer OY
Neurology · 205d
Cleared Sep 25, 2019
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser...
K190875 · HQC
D.O.R.C. Dutch Ophthalmic Research...
Ophthalmic · 174d
Cleared Sep 25, 2019
ARIES MRSA Assay
K191742 · NQX
Luminex Corporation
Microbiology · 86d
Cleared Sep 25, 2019
OMNI TiN Coated Apex Knee™ System
K191765 · JWH
Omni Life Science, Inc.
Orthopedic · 86d
Cleared Sep 25, 2019
TranS1 Interbody Fusion System
K191791 · MAX
Trans1
Orthopedic · 84d
Cleared Sep 25, 2019
PhoeniX
K192011 · IZL
Sedecal., Sa.
Radiology · 58d
Cleared Sep 25, 2019
Thermoplastic Masks
K192102 · IYE
Aktina Medical Corporation
Radiology · 51d
Cleared Sep 24, 2019
Novidia Universal Bond
K183391 · KLE
Nobio , Ltd.
Dental · 291d
Cleared Sep 24, 2019
Patient Assistant Model PA97000
K190574 · DSI
Medtronic, Inc.
Cardiovascular · 202d
Cleared Sep 24, 2019
EasiSlush
K191006 · KDN
Bridge TO Life, Ltd.
Gastroenterology & Urology · 161d
Cleared Sep 24, 2019
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM...
K191212 · PGM
Medos International SARL
Orthopedic · 141d
Cleared Sep 24, 2019
Buhlmann fCAL turbo and CALEX Cap
K191718 · NXO
Buhlmann Laboratories AG
Immunology · 90d
Cleared Sep 24, 2019
Mako Total Hip Application, Mako Total Knee Application
K191998 · OLO
Mako Surgical Corp.
Orthopedic · 60d
Cleared Sep 24, 2019
SmoothSkin BARE+
K192010 · OHT
Cyden Limited
General & Plastic Surgery · 57d
Cleared Sep 24, 2019
Innovasis Gibralt Spine System
K192354 · NKG
Innovasis, Inc.
Orthopedic · 26d
Cleared Sep 23, 2019
USTAR II System
K190100 · KRO
United Orthopedic Corporation
Orthopedic · 244d
Cleared Sep 23, 2019
SPIRA Open Matrix ALIF and LLIF
K190483 · MAX
Camber Spine Technologies
Orthopedic · 208d
Cleared Sep 23, 2019
T-Stat 2.0 Microvascular Tissue Oximeter
K192322 · MUD
Spectros Corporation
General & Plastic Surgery · 27d
Cleared Sep 21, 2019
Medi-Direct TENS Pen
K182671 · NUH
Jkh USA, LLC
Neurology · 360d
Cleared Sep 20, 2019
INTAI Surgery Navigation System
K180523 · OLO
Intai Technology Corporation
Orthopedic · 570d
Cleared Sep 20, 2019
Clyra Wound Irrigation Solution
K181428 · FRO
Clyra Medical Technologies, Inc.
General & Plastic Surgery · 476d
Cleared Sep 20, 2019
Supercath 5
K190001 · FOZ
Togo Medikit Co., Ltd.
General Hospital · 261d