FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
115537–115560 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 27, 1993
THE KAUFMANN LIFT-AND-TURN MATTRESS
K915306 · FNM
Kaufmann Sjukvardsartiklar
General Hospital · 433d
Cleared Jan 27, 1993
STERILE GAUZE PADS
K915591 · NAB
Eagle Medical, Inc.
General & Plastic Surgery · 411d
Cleared Jan 27, 1993
RACK AND SYRINGES
K915780 · FMF
Normeca Corp.
General Hospital · 400d
Cleared Jan 27, 1993
TECNOL FLUIDSHIELD INFECTION CONTROL MASK
K915817 · FXX
Tecnol Medical Products, Inc.
General Hospital · 394d
Cleared Jan 27, 1993
TECNOL FLUIDSHIELD W/SPLASHGUARD VIS INFEC CONT MK
K920162 · FXX
Tecnol Medical Products, Inc.
General Hospital · 379d
Cleared Jan 27, 1993
PHARMASEAL CLEAR HUB SPINAL NEEDLE
K920305 · BSP
Baxter Healthcare Corp
Anesthesiology · 371d
Cleared Jan 27, 1993
CURITY CALIBRATED TUOHY TYPE EPIDURAL NEEDLE
K921288 · BSP
Kendall Healthcare Products Co....
Anesthesiology · 316d
Cleared Jan 27, 1993
SPIROLITE MODEL MSC-201 SPIROMETER
K921513 · BZG
Medical Systems Corp.
Anesthesiology · 302d
Cleared Jan 27, 1993
SUNGLASSES
K922464 · HQY
Wing Shing Optical Manufacturers , Ltd.
Ophthalmic · 246d
Cleared Jan 27, 1993
VTI OXYGEN ANALYZER
K922738 · CCL
Vascular Technology Incorporated
Anesthesiology · 233d
Cleared Jan 27, 1993
THERM O DRUG MODEL HT-747
K922786 · LGZ
C.F. Electronics, Inc.
General Hospital · 232d
Cleared Jan 27, 1993
ROCHE COBAS FUTURA GLUCOSE
K922811 · CFR
Roche Diagnostic Systems, Inc.
Chemistry · 231d
Cleared Jan 27, 1993
VINYL EXAM GLOVES
K922968 · LYZ
Normandin Pacific Holdings Corp.
General Hospital · 222d
Cleared Jan 27, 1993
MEDISONIC OXYGEN FLOW CONTROLLER
K923660 · NFB
Medisonic U.S.A., Inc.
Anesthesiology · 189d
Cleared Jan 27, 1993
N-PAC
K923688 · KKX
National Healthcare Linen Service
General Hospital · 188d
Cleared Jan 27, 1993
SURGICAL GOWN PACK
K923798 · KKX
Central Georgia Ancillary Health Systems
General Hospital · 191d
Cleared Jan 27, 1993
MID LABS, INC. VIT MATE
K924222 · HQE
Medical Instrument Development...
Ophthalmic · 159d
Cleared Jan 27, 1993
HYPOALLERGENIC LATEX GLOVES
K924633 · LYY
Pan-Century Rubber Products Sdn. Bhd.
General Hospital · 141d
Cleared Jan 27, 1993
HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT
K924637 · GFO
International Technidyne Corp.
Hematology · 148d
Cleared Jan 27, 1993
BURTON HAND HELD SLIT LAMP - MODEL SL750
K924770 · HJO
R.H. Burton Co.
Ophthalmic · 126d
Cleared Jan 27, 1993
BURTON SLIT LAMP - MODEL 2000
K924782 · HJO
R.H. Burton Co.
Ophthalmic · 126d
Cleared Jan 27, 1993
BURTON SLIT LAMP
K924787 · HJO
R.H. Burton Co.
Ophthalmic · 126d
Cleared Jan 27, 1993
TELERADIOLOGY DEVICE & COMPONENT OF PACS COMPONENT
K925465 · LLZ
Life Care Imaging
Radiology · 90d
Cleared Jan 27, 1993
ACCESS(R) FREE T4 ASSAY
K925913 · CEC
Bio-Rad Laboratories, Inc.
Toxicology · 65d