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
70897–70920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 30, 2003
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
K031656 · MNS
Respironics, Inc.
Anesthesiology · 63d
Cleared Jul 30, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE...
K031699 · LON
Becton, Dickinson & CO
Microbiology · 58d
Cleared Jul 30, 2003
PASCO MIC AND MIC/ID PANELS, GEMIFLOXACIN
K031727 · JWY
Pasco Laboratories, Inc.
Microbiology · 57d
Cleared Jul 30, 2003
MR FIBER OPTIC ECG GATING SYSTEM
K031731 · LNH
Sa Instruments, Inc.
Radiology · 56d
Cleared Jul 30, 2003
PEEK TETRIS SPINAL IMPLANT
K031757 · MQP
Signus Medical, LLC
Orthopedic · 54d
Cleared Jul 30, 2003
VERTE-STACK SPINAL SYSTEM
K031780 · MQP
Medtronic Sofamor Danek
Orthopedic · 50d
Cleared Jul 30, 2003
POWERHEART AED G3, MODEL 9300
K031987 · MKJ
Cardiac Science
Cardiovascular · 33d
Cleared Jul 30, 2003
DXAVIEW SPINE AND HIP, MODEL QCT-3D PLUS
K031991 · KGI
Image Analysis, Inc.
Radiology · 33d
Cleared Jul 30, 2003
8 CHANNEL CARDIAC PHASED ARRAY COIL
K032045 · MOS
GE Medical Systems
Radiology · 28d
Cleared Jul 30, 2003
MODIFICATION TO REPROCESSED SYNTHES EXTERNAL FIXATION DEVICES
K032058 · KTT
Alliance Medical Corp.
Orthopedic · 28d
Cleared Jul 30, 2003
AURORA
K032082 · LNH
Aurora Imaging Technology, Inc.
Radiology · 23d
Cleared Jul 30, 2003
ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC
K032089 · JJY
Roche Diagnostics Corp.
Chemistry · 23d
Cleared Jul 29, 2003
REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE
K031550 · DQK
Vivometrics, Inc.
Cardiovascular · 74d
Cleared Jul 29, 2003
BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
K031647 · JOJ
Getinge USA, Inc.
General Hospital · 63d
Cleared Jul 29, 2003
BENCO SPHERICAL
K031658 · EJJ
Southern Dental Industries, Inc.
Dental · 62d
Cleared Jul 29, 2003
MIX2VIAL TRANSFER DEVICE
K031861 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 43d
Cleared Jul 29, 2003
VIRTUOSAPH
K031891 · GCJ
Terumo Cardiovascular Systems Corp.
General & Plastic Surgery · 46d
Cleared Jul 29, 2003
STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)
K032062 · GEI
Stellartech Research Corp.
General & Plastic Surgery · 26d
Cleared Jul 28, 2003
SINCLAIR WOUND AND SKIN EMULSION
K024367 · MGQ
Sinclair Pharmaceuticals, Ltd.
General & Plastic Surgery · 209d
Cleared Jul 28, 2003
REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
K030170 · OCW
Opus Medical, Inc.
Gastroenterology & Urology · 192d
Cleared Jul 28, 2003
OSSEOTITE NT CERTAIN IMPLANTS
K031475 · DZE
Implant Innovations, Inc.
Dental · 80d
Cleared Jul 28, 2003
AIRBRUSH LIPOSCULPTOR SYSTEM
K031881 · QPB
Biosculpture Technology, Inc.
General & Plastic Surgery · 40d
Cleared Jul 28, 2003
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
K031969 · FTM
DePuy Orthopaedics, Inc.
General & Plastic Surgery · 32d
Cleared Jul 28, 2003
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50...
K032007 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 28d