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
71017–71040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 17, 2003
GALT MEDICAL GUIDEWIRE
K031916 · DQX
Galt Medical Corp.
Cardiovascular · 27d
Cleared Jul 17, 2003
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR AND ACCESSORIES (E.G., RITA...
K031926 · GEI
Rita Medical Systems, Inc.
General & Plastic Surgery · 24d
Cleared Jul 17, 2003
BAYLIS PAIN MANAGEMENT GENERATOR, MODELS PMG-115-TD AND PMG-230-TD
K031950 · GEI
Baylis Medical Co., Inc.
General & Plastic Surgery · 23d
Cleared Jul 17, 2003
MODIFICATION TO HERMES O.R. CONTROL CENTER
K031956 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 22d
Cleared Jul 17, 2003
PHILLIPS OMNIDIAGNOST ELEVA
K032046 · OWB
Philips Medical Systems, Inc.
Radiology · 15d
Cleared Jul 17, 2003
RADIUS 018 COUGAR WIRE
K032129 · DQX
Radius Medical Technologies, Inc.
Cardiovascular · 7d
Cleared Jul 16, 2003
ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
K030960 · FAJ
Acmi Corporation
Gastroenterology & Urology · 111d
Cleared Jul 16, 2003
BIO-LOGIC INSERT EARPHONES
K031352 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 78d
Cleared Jul 16, 2003
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
K031376 · MHX
Ge Medical Systems Information...
Cardiovascular · 76d