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
100417–100440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 20, 1995
LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM
K953903 · GCJ
Core Dynamics, Inc.
General & Plastic Surgery · 92d
Cleared Oct 20, 1995
DISPOSABLE HME/FILTER
K954194 · BYD
Engstrom Medical
Anesthesiology · 44d
Cleared Oct 20, 1995
QUICKVUE IN-LINE ONE STEP STREP A TEST (MODIFICATION)
K954257 · GTZ
Quidel Corp.
Microbiology · 85d
Cleared Oct 20, 1995
ACCESS PROLACTIN ASSAY (MODIFICATION)
K954680 · CFT
Bio-Rad Laboratories, Inc.
Chemistry · 18d
Cleared Oct 19, 1995
DPX TISSUE QUANTIFICATION OUTPUT
K935454 · JAK
Lunar Corp.
Radiology · 706d
Cleared Oct 19, 1995
VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT
K940003 · GKZ
Buckman Co., Inc.
Hematology · 654d
Cleared Oct 19, 1995
BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS
K942651 · KTH
Casa Futura Technologies
Ear, Nose, Throat · 503d
Cleared Oct 19, 1995
CORDIS HORIZONTAL-VERICAL VALVE SYSTEM
K944595 · JXG
Cordis Corp.
Neurology · 395d
Cleared Oct 19, 1995
BOEHRINGER AUTOVAC(R) 7900 SERIES
K945775 · CAC
Boehringer Laboratories
Anesthesiology · 328d
Cleared Oct 19, 1995
DECOMAT 4656
K950566 · LDS
Getinge Disinfection, Inc.
General Hospital · 253d
Cleared Oct 19, 1995
PISTON SYRINGE
K951025 · FMF
Pharmacia, Inc.
General Hospital · 227d
Cleared Oct 19, 1995
CPR MICROMASK
K951483 · CBP
Plasco, Inc.
Anesthesiology · 203d
Cleared Oct 19, 1995
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
K951496 · GKZ
Abbott Laboratories
Hematology · 248d
Cleared Oct 19, 1995
INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM
K951627 · MPA
Infinitech, Inc.
Ophthalmic · 195d
Cleared Oct 19, 1995
EPILATOR
K952117 · KCX
Burke Neutech, Inc.
General & Plastic Surgery · 167d
Cleared Oct 19, 1995
EAGLE 3000 PATIENT MONITOR
K952474 · DRT
Marquette Electronics, Inc.
Cardiovascular · 142d
Cleared Oct 19, 1995
ROYAL SHIELD NON-STERILE POWDER-FREE RUBBER DAMS
K952628 · EIE
Elastomade Accessories Sdn Bhd
Dental · 133d
Cleared Oct 19, 1995
6200 VITAL SIGNS MONITOR
K953415 · DPS
Bci Intl., Inc.
Cardiovascular · 91d
Cleared Oct 19, 1995
ELX800UV
K953572 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 80d
Cleared Oct 19, 1995
TECA PREMIERE
K953732 · GWJ
Medelec , Ltd.
Neurology · 80d
Cleared Oct 19, 1995
MEDI-OXIDE STERILZATION POUCH FROM MEDI-PLUS
K953749 · KCT
Curwood, Inc.
General Hospital · 69d
Cleared Oct 19, 1995
POWDERFREE LATEX GLOVE
K953986 · LYY
Steriltx
General Hospital · 57d
Cleared Oct 19, 1995
EASI-JECTOR CONTROL SYSTEM
K954189 · FMF
North, Inc.
General Hospital · 43d
Cleared Oct 19, 1995
BUHLMANN ANGIOSTENSIN II RIA
K954299 · CIB
Buhlmann Laboratories AG
Chemistry · 35d