FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
71521–71544 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2003
MX 300 OXYGEN MONITOR
K024155 · CCL
Teledyne Analytical Instruments
Anesthesiology · 212d
Cleared Jul 17, 2003
RX300 OXYGEN ANALYZER
K024228 · CCL
Teledyne Analytical Instruments
Anesthesiology · 206d
Cleared Jul 17, 2003
SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM
K030087 · NKB
Spinal Concepts, Inc.
Orthopedic · 189d
Cleared Jul 17, 2003
UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED
K030158 · GEI
Walsh Medical Devices, Inc.
General & Plastic Surgery · 182d
Cleared Jul 17, 2003
POLYGRAFT BONE GRAFT SUBSTITUTE
K030288 · MQV
Osteobiologics, Inc.
Orthopedic · 170d
Cleared Jul 17, 2003
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS
K030342 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 164d
Cleared Jul 17, 2003
CEFAR REHAB 2 AND REHAB 2 PRO
K030403 · IPF
Cefar Medical AB
Physical Medicine · 161d
Cleared Jul 17, 2003
OMNILUX RED
K030426 · GEX
Photo Therapeutics Limited
General & Plastic Surgery · 157d
Cleared Jul 17, 2003
POWER LASER 90
K030692 · NHN
Andi Electromedical Aps
Physical Medicine · 134d
Cleared Jul 17, 2003
TAGA VELOCITY HUMIDIFIER
K031179 · BTT
Taga Medical Technologies, Inc.
Anesthesiology · 93d
Cleared Jul 17, 2003
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
K031211 · DQY
Medtronic Vascular
Cardiovascular · 91d
Cleared Jul 17, 2003
MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE
K031216 · NEW
Aesculap
General & Plastic Surgery · 91d
Cleared Jul 17, 2003
LORDEX POWER TRACTION EQUIPMENT
K031227 · ITH
Ever Prosperous Instrument, Inc.
Physical Medicine · 90d
Cleared Jul 17, 2003
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
K031247 · GEI
Medtronic Vascular
General & Plastic Surgery · 90d
Cleared Jul 17, 2003
OSTEO-G BONE VOID FILLER SYSTEM
K031319 · MQV
Aspine USA, Inc.
Orthopedic · 83d
Cleared Jul 17, 2003
ACUMED SMALL BONE LOCKING ROD SYSTEM II
K031438 · HSB
Acumed, LLC
Orthopedic · 72d
Cleared Jul 17, 2003
GLASIONOMER FX-II
K031467 · EMA
Shofu Dental Corp.
Dental · 70d
Cleared Jul 17, 2003
XPECT INFLUENZA A/B
K031565 · PSZ
Remel, Inc.
Microbiology · 59d
Cleared Jul 17, 2003
FERRITIN GENERATION 2
K031650 · DBF
Roche Diagnostics Corp.
Immunology · 50d
Cleared Jul 17, 2003
MENTOR OBTAPE TRANS-OBTURATOR TAPE
K031767 · OTN
Mentor Corp.
Gastroenterology & Urology · 38d
Cleared Jul 17, 2003
CELLPLEX TCP SYNTHETIC CANCELLOUS BONE
K031817 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 35d
Cleared Jul 17, 2003
NATURALASE LP ND:YAG LASER
K031828 · GEN
Focus Medical, LLC
General & Plastic Surgery · 34d
Cleared Jul 17, 2003
COBAS INTEGRA CARBON DIOXIDE ASSAY
K031879 · KHS
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jul 17, 2003
XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM
K031893 · KWP
Howmedica Osteonics Corp.
Orthopedic · 28d