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
80617–80640 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 2000
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · NFB
Invacare Corp.
Anesthesiology · 90d
Cleared Oct 24, 2000
ELRAN 01 SYSTEM
K002431 · GCJ
Envision Advanced Medical System, Ltd.
General & Plastic Surgery · 77d
Cleared Oct 24, 2000
SIMPLICITY SOFT INFUSION SET
K002492 · FPA
Sterling Medivations, Inc.
General Hospital · 71d
Cleared Oct 24, 2000
EQUITY
K002826 · EJT
Jensen Industries, Inc.
Dental · 43d
Cleared Oct 24, 2000
ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903 · HBE
The Anspach Effort, Inc.
Neurology · 36d
Cleared Oct 24, 2000
DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE,...
K002975 · LYY
Wrp Specialty Products Sdn. Bhd.
General Hospital · 32d
Cleared Oct 24, 2000
MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW
K003091 · LYZ
Medline Industries, Inc.
General Hospital · 21d
Cleared Oct 24, 2000
SOMATOM SMILE
K003152 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 14d
Cleared Oct 24, 2000
HEATED HUMIDIFIER
K983783 · BTT
Pegasus Research Corp.
Anesthesiology · 728d
Cleared Oct 23, 2000
DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING...
K000838 · LYY
P.T. Healthcare Glovindo
General Hospital · 223d
Cleared Oct 23, 2000
DMLC IV-ERGO
K001163 · IXI
3D Line USA, Inc.
Radiology · 196d
Cleared Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
K001468 · MOI
Roche Diagnostics Corp.
Immunology · 166d
Cleared Oct 23, 2000
RADIONICS RF DISC CATHETER ELECTRODE SYSTEM
K001741 · HRX
Radionics, Inc.
Orthopedic · 137d
Cleared Oct 23, 2000
DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES
K001990 · GEX
Depilase Group , Ltd.
General & Plastic Surgery · 116d
Cleared Oct 23, 2000
MR-III
K002261 · GAS
Smith & Nephew, Inc.
General & Plastic Surgery · 90d
Cleared Oct 23, 2000
BROOKER FEMORAL NAILS
K002278 · HSB
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Oct 23, 2000
THERMAL CAUTERY UNIT, MODEL 150
K002341 · HQO
Geiger Medical Technologies, Inc.
Ophthalmic · 83d
Cleared Oct 23, 2000
BAYLIS PAIN MANAGEMENT PROBE/PMP-20-145 AND BAYLIS PAIN MANAGEMENT CONNECTOR...
K002389 · GXI
Baylis Medical Co., Inc.
Neurology · 80d
Cleared Oct 23, 2000
RE-ENTRANT CHAMBER, MODEL 1008 OR 44D
K002446 · KXK
Sun Nuclear Corp.
Radiology · 75d
Cleared Oct 23, 2000
X-POSURE SYSTEM VERSION 2 RAD
K002500 · KGI
Pronosco A/S
Radiology · 70d
Cleared Oct 23, 2000
REUSABLE CANNULA
K002542 · GCJ
Genicon, LC
General & Plastic Surgery · 68d
Cleared Oct 23, 2000
OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
K002589 · LPN
Alcon Universal, Ltd.
Ophthalmic · 63d
Cleared Oct 23, 2000
BIOSLEEP
K002622 · OLZ
Oxford Biosignals Limited
Neurology · 61d
Cleared Oct 23, 2000
ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG
K002631 · OLX
Eemagine Medical Imaging Solutions GmbH
Neurology · 61d