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
74641–74664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2002
RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
K022018 · LJM
Rhigene, Inc.
Immunology · 15d
Cleared Jul 03, 2002
BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
K002741 · JOJ
Albert Browne , Ltd.
General Hospital · 670d
Cleared Jul 03, 2002
CLEARMEDICAL/NELLCOR OXISENSOR II, ADULT, MODEL D-25/D-25L
K012600 · NLF
Clearmedical, Inc.
Anesthesiology · 324d
Cleared Jul 03, 2002
CLEARMEDICAL/NELLCOR OXISENSOR II, NEONATAL/ADULT, MODEL N-25
K012609 · NLF
Clearmedical, Inc.
Anesthesiology · 324d
Cleared Jul 03, 2002
CLEARMEDICAL/NELLCOR OXISENSOR II, PEDIATRIC, MODEL D-20
K012622 · NLF
Clearmedical, Inc.
Anesthesiology · 324d
Cleared Jul 03, 2002
POWERED MUSCLE STIMULATOR
K013768 · IPF
Theratech, Inc.
Physical Medicine · 232d
Cleared Jul 03, 2002
FIBIOCORE
K020431 · ELR
Est. Anthogyr
Dental · 145d
Cleared Jul 03, 2002
CARESIDE LDH
K020484 · CFH
Careside, Inc.
Chemistry · 140d
Cleared Jul 03, 2002
POLY-CHEM GLUCOSE
K020852 · CFR
Polymedco, Inc.
Chemistry · 110d
Cleared Jul 03, 2002
LIGHT SABER SPINAL NEEDLE
K021084 · FMF
Minrad, Inc.
Radiology · 90d
Cleared Jul 03, 2002
INTROCAN SAFETY IV CATHETER
K021094 · DYB
B.Braun Medical, Inc.
Cardiovascular · 90d
Cleared Jul 03, 2002
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
K021159 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 83d
Cleared Jul 03, 2002
SEEDNET SYSTEM AND SEEDNETGOLD SYSTEM, MODELS GP6T5, GP5T5, GP5T3, HP5T5 & HP5T3
K021261 · GEH
Galil Medical , Ltd.
General & Plastic Surgery · 75d
Cleared Jul 03, 2002
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC...
K021332 · CGS
Wiener Laboratories Saic
Chemistry · 68d
Cleared Jul 03, 2002
AART PECTORALIS IMPLANT
K021337 · MIC
Aesthetic and Reconstructive...
General & Plastic Surgery · 68d
Cleared Jul 03, 2002
MAC-LAB/CARDIOLAB EP/COMBOLAB
K021366 · DQK
General Electric Medical Systems...
Cardiovascular · 64d
Cleared Jul 03, 2002
COALESCENT SURGICAL U-CLIP - OR OTHER TBD AND ACCESSORIES
K021407 · FZP
Coalescent Surgical
General & Plastic Surgery · 61d
Cleared Jul 03, 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
K021453 · MKJ
Philips Medical Systems
Cardiovascular · 58d
Cleared Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827 · NBW
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jul 03, 2002
SCS CLARIS SPINAL SYSTEM,REXTENDED OMNIAXIAL CONNECTOR-,MEDIUM, MODEL CO05,...
K021919 · KWP
Ortho Tec, LLC
Orthopedic · 22d
Cleared Jul 03, 2002
TRELLIS PLUS INFUSION SYSTEM (140CM CATHETER LENGTH 10CM INFUSION LENGTH 20CM...
K021958 · QEY
Bacchus Vascular, Inc.
Cardiovascular · 19d
Cleared Jul 02, 2002
CRANIAL STEREOTACTIC EQUIPMENT
K010065 · IYE
Arplay Medical S.A.
Radiology · 540d
Cleared Jul 02, 2002
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
K013205 · DRQ
Millar Instruments, Inc.
Cardiovascular · 280d
Cleared Jul 02, 2002
RE-ENTRANT CHAMBER
K013689 · KPT
Sun Nuclear Corp.
Radiology · 238d