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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
120601–120624 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1991
TECNADYNE SURGI-SQUEEZE INFUSION PUMP
K910926 · KZD
Tecnadyne Scientific, Inc.
General Hospital · 150d
Cleared Aug 02, 1991
HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED
K910950 · BZG
Vitalog Monitoring,Inc.
Anesthesiology · 157d
Cleared Aug 02, 1991
OHMEDA MODEL 4700 OXICAP
K911193 · CCK
Ohmeda Medical
Anesthesiology · 137d
Cleared Aug 02, 1991
CALIBRATION KIT
K911264 · BXK
S & W Medico Teknik
Anesthesiology · 144d
Cleared Aug 02, 1991
ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE
K911520 · KKX
Andronic Devices, Ltd.
General Hospital · 120d
Cleared Aug 02, 1991
ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP
K911521 · KKX
Andronic Devices, Ltd.
General Hospital · 120d
Cleared Aug 02, 1991
DUAL COMPARTMENT TPN BAG 3 LITER
K911567 · KPE
Stedim, Inc.
General Hospital · 115d
Cleared Aug 02, 1991
STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD
K911637 · HAD
Personal Products Co.
Neurology · 113d
Cleared Aug 02, 1991
3RD HAND HELPER
K911815 · FPA
Aaron Medical Industries
General Hospital · 100d
Cleared Aug 02, 1991
DYNAVISION 2000
K911938 · LQD
Performance Ent.
Neurology · 93d
Cleared Aug 02, 1991
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
K911964 · FRN
Abbott Laboratories
General Hospital · 92d
Cleared Aug 02, 1991
LUMATAG T4 CHEMILUMINESCENCE ASSAY
K911985 · CDX
London Diagnostics, Inc.
Chemistry · 88d
Cleared Aug 02, 1991
FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES
K912022 · NAD
Fraass Survival Systems, Inc.
General & Plastic Surgery · 87d
Cleared Aug 02, 1991
MODIFIED LIFECARE MODEL 175 INFUSER
K912092 · FRN
Abbott Laboratories
General Hospital · 81d
Cleared Aug 02, 1991
CARDIAC SPECT PALLET
K912286 · IYZ
Siemens Gammasonics, Inc.
Radiology · 71d
Cleared Aug 02, 1991
PEACE MODEL 100 CUFF MONITOR
K912352 · BSK
Peace Medical, Inc.
Anesthesiology · 66d
Cleared Aug 02, 1991
ECT CARBON FIBER PALLET, MODIFICATION
K912481 · IYZ
Siemens Gammasonics, Inc.
Radiology · 71d
Cleared Aug 02, 1991
GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER
K912555 · JAQ
Rts Technology, Inc.
Radiology · 52d
Cleared Aug 02, 1991
TANGENT IV
K912586 · IXR
Fischer Imaging Corp.
Radiology · 51d
Cleared Aug 02, 1991
MOUTH TO MASK RESUSCITATOR
K912625 · BTM
Vital Signs, Inc.
Anesthesiology · 50d
Cleared Aug 02, 1991
BOLUS XENON CIRCUIT
K912626 · IYT
Vital Signs, Inc.
Radiology · 50d
Cleared Aug 02, 1991
MONOSCOPY(TM) BRAND, DUAL SUCTION/IRRIGATION CONTR
K912750 · GCJ
Dexide, Inc.
General & Plastic Surgery · 42d
Cleared Aug 02, 1991
LATEX EXAMINATION GLOVES
K912988 · LYY
La Glove (M) Sdn. Bhd.
General Hospital · 28d
Cleared Aug 02, 1991
HEART NEBULIZER POLE CLAMP
K913000 · CAF
B&B Medical Technologies, Inc.
Anesthesiology · 25d