Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
54145–54168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 2009
PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016,...
K083619 · HWC
Parcus Medical, LLC
Orthopedic · 88d
Cleared Mar 06, 2009
SOMNOLYZER 24X7
K083620 · MNR
The Siesta Group North America
Anesthesiology · 88d
Cleared Mar 06, 2009
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K083642 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 87d
Cleared Mar 06, 2009
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
K083694 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Mar 06, 2009
BLACK NITRILE EXAMINATION GLOVES
K083908 · LZA
Innovative Gloves Co;, Ltd.
General Hospital · 66d
Cleared Mar 06, 2009
D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT
K090073 · OMG
Diagnostic Hybrids, Inc.
Microbiology · 53d
Cleared Mar 06, 2009
PARCUS V-LOX TITANIUM SUTURE ANCHOR,MODELS: 10251, 10252, 10257, 10258
K090075 · MBI
Parcus Medical, LLC
Orthopedic · 53d
Cleared Mar 06, 2009
ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE
K090084 · GEX
Merit Medical Systems, Inc.
General & Plastic Surgery · 53d
Cleared Mar 06, 2009
EXPEDIUM SPINE SYSTEM
K090230 · NKB
Depuy Spine, Inc.
Orthopedic · 35d
Cleared Mar 05, 2009
MERCURY MEDICAL PEEP VALVE
K081266 · BYE
Mercury Enterprizes Dba Mercury Medical
Anesthesiology · 304d
Cleared Mar 05, 2009
QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100
K083079 · DQA
Quanta Computer, Inc.
Anesthesiology · 140d
Cleared Mar 05, 2009
EMU-GRAPH 4 EMULATOR, MODEL CI 144
K083650 · JOJ
Steritec Products, Inc.
General Hospital · 86d
Cleared Mar 05, 2009
TRACH-ASSIST
K083702 · BZA
Mergenet Medical
Anesthesiology · 80d
Cleared Mar 05, 2009
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR,...
K083755 · LZA
Siam Sempermed Corp., Ltd.
General Hospital · 78d
Cleared Mar 05, 2009
CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S
K083776 · FPD
Corpak Medsystems
Gastroenterology & Urology · 76d
Cleared Mar 05, 2009
V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
K090001 · HCG
MicroVention, Inc.
Neurology · 62d
Cleared Mar 05, 2009
GE DATEX-OHMEDA AISYS
K090233 · BSZ
Datex-Ohmeda, Inc.
Anesthesiology · 34d
Cleared Mar 05, 2009
BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1,...
K090501 · NEU
Biopsy Sciences, LLC
General & Plastic Surgery · 8d
Cleared Mar 05, 2009
CSBP-001A BODY PERFUSION SYSTEM
K090504 · JAK
Toshibamedical Systems Corporation
Radiology · 7d
Cleared Mar 04, 2009
MESA SPINAL SYSTEM
K080611 · MNH
K2m, Inc.
Orthopedic · 365d
Cleared Mar 04, 2009
LABORPRO SYSTEM
K081984 · NPB
Trig Medical, Ltd.
Obstetrics & Gynecology · 236d
Cleared Mar 04, 2009
M-50 SERIES SPO2 SENSOR
K082487 · DQA
Beijing Choice Electronic Technololgy...
Anesthesiology · 188d
Cleared Mar 04, 2009
NANGEL
K083005 · LYC
Teknimed, S.A.
Dental · 147d
Cleared Mar 04, 2009
MODIFICATION TO SECURACATH, MODEL: SPK01
K083081 · OKC
Interrad Medical, Inc.
General Hospital · 139d