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
71761–71784 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 2003
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
K031200 · FMI
Becton, Dickinson & CO
General Hospital · 69d
Cleared Jun 24, 2003
SYNVITRO HYADASE
K031228 · MQL
Medicult A/S
Obstetrics & Gynecology · 67d
Cleared Jun 24, 2003
BAYER ADVIA CENTAUR CA 19-9 ASSAY
K031393 · NIG
Bayer Healthcare, LLC
Immunology · 53d
Cleared Jun 24, 2003
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
K031460 · BZD
Respironics, Inc.
Anesthesiology · 47d
Cleared Jun 24, 2003
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
K031572 · LPH
Zimmer, Inc.
Orthopedic · 35d
Cleared Jun 24, 2003
U & I AMERICA SPINAL HOOK SYSTEM
K031595 · KWP
U&I Corp., America
Orthopedic · 34d
Cleared Jun 24, 2003
SPECTRAPULSE
K031680 · GEX
Primary Technology, LLC
General & Plastic Surgery · 25d
Cleared Jun 24, 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725 · KTT
Synthes (Usa)
Orthopedic · 21d
Cleared Jun 24, 2003
ENDO GATOR SYSTEM
K031773 · OCX
Byrne Medical, Inc.
Gastroenterology & Urology · 15d
Cleared Jun 24, 2003
NITREX NITINOL GUIDEWIRE
K031864 · DQX
Ev3 Corporation
Cardiovascular · 8d
Cleared Jun 23, 2003
MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED...
K023333 · HIS
Pleasure Latex Products Sdn. Bhd.
Obstetrics & Gynecology · 259d
Cleared Jun 23, 2003
PER, MODEL MEMO
K030218 · DXH
Medical Monitors Pty., Ltd.
Cardiovascular · 153d
Cleared Jun 23, 2003
BERKELEY V-10 VACUUM CURETTAGE SYSTEM
K030935 · HHI
Acmi Corporation
Obstetrics & Gynecology · 90d
Cleared Jun 23, 2003
EMBRYOGLUE
K031015 · MQL
Vitrolife Sweden AB
Obstetrics & Gynecology · 84d
Cleared Jun 23, 2003
ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY
K031038 · NBC
Bayer Healthcare, LLC
Chemistry · 83d
Cleared Jun 23, 2003
SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
K031065 · MEG
Syringex Medical, Inc.
General Hospital · 81d
Cleared Jun 23, 2003
HEMOBAG, MODEL HBBSD2000
K031150 · DTN
Global Blood Resources, LLC
Cardiovascular · 74d
Cleared Jun 23, 2003
JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
K031346 · OBJ
Jomed, Inc.
Cardiovascular · 55d
Cleared Jun 23, 2003
3TP SOFTWARE OPTION
K031350 · LNH
3tp, LLC
Radiology · 55d
Cleared Jun 23, 2003
VIVATHERM THEMPERATURE MEASUREMENT SYSTEM
K031556 · FLL
Vivant Medical, Inc.
General Hospital · 35d
Cleared Jun 23, 2003
DEPUY ACROMED VBR SYSTEM
K031635 · MQP
Depuyacromed
Orthopedic · 27d
Cleared Jun 20, 2003
NLITE SYSTEM, MODEL#: A00-1025/A00-1033
K024189 · GEX
Icn Photonics , Ltd.
General & Plastic Surgery · 183d
Cleared Jun 20, 2003
REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200
K024243 · MCW
Fox Hollow Technologies
Cardiovascular · 179d
Cleared Jun 20, 2003
PULSED LIGHT THERAPY SYSTEM, MODEL# UV-300
K024259 · GEX
New Star Lasers, Inc.
General & Plastic Surgery · 179d