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
108625–108648 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1994
WAVE FLUORESCENT MAGNIFIER
K936088 · KZF
Burton Medical Products Corp.
General Hospital · 126d
Cleared Apr 26, 1994
SYSTEM WASHER 100
K936258 · JQW
Eg&G Berthold
Chemistry · 117d
Cleared Apr 26, 1994
GLYCATED PROTEIN CONTROLS
K940142 · JJX
Primus Corp.
Hematology · 105d
Cleared Apr 26, 1994
ACCESS CORTISOL REAGENTS
K940221 · CGR
Bio-Rad Laboratories, Inc.
Toxicology · 98d
Cleared Apr 26, 1994
CIBA CORNING ACS FT3 IMMUNOASSAY
K940482 · CEC
Ciba Corning Diagnostics Corp.
Chemistry · 83d
Cleared Apr 26, 1994
ACUFEX ARTHROSCOPIC SUTURE CUTTER
K940506 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 82d
Cleared Apr 26, 1994
MANUAL STETOSCOPE
K940578 · LDE
Bhs Intl., Inc.
Cardiovascular · 77d
Cleared Apr 26, 1994
ACUFEX SURETAC IXC SYSTEMS
K940623 · HRX
Acufex Microsurgical, Inc.
Orthopedic · 71d
Cleared Apr 26, 1994
CONVERTORS OPTI-SORB DRAPE MATERIAL
K940702 · KKX
Baxter Healthcare Corp
General Hospital · 69d
Cleared Apr 26, 1994
TECNADYNE ENDOSCOPIC INSTRUMENT HOLDER
K940891 · GCJ
Tecnadyne Scientific, Inc.
General & Plastic Surgery · 60d
Cleared Apr 26, 1994
CEDIA T4 MAB ASSAY
K941042 · KLI
Microgenics Corp.
Chemistry · 50d
Cleared Apr 26, 1994
TECHNISON AXON SYSTEM
K941156 · KHS
Miles, Inc.
Chemistry · 47d
Cleared Apr 26, 1994
SYNERMED ISE REAGENTS
K941400 · JGS
Synermed, Inc.
Chemistry · 35d
Cleared Apr 26, 1994
CAREMOR CLINER
K941569 · INM
Winco, Inc.
Physical Medicine · 26d
Cleared Apr 26, 1994
AURAL-CAM, VIDEO EAR, VID RX
K941659 · ERA
Gracefully Yours, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 25, 1994
CD8 CYTOSPHERES KIT
K923951 · MAM
Coulter Electronics, Inc.
Hematology · 627d
Cleared Apr 25, 1994
ZYMED HOLTER SCANNER MODEL 2010
K930806 · DQK
Agilent Technologies
Cardiovascular · 433d
Cleared Apr 25, 1994
BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600)
K930887 · GCJ
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 430d
Cleared Apr 25, 1994
BAUMER PLATES
K930966 · HRS
Baumer Ortopedia , Ltd.
Orthopedic · 425d
Cleared Apr 25, 1994
BIRTCHER MAGNETIC RETRIEVER (GS-3100)
K931654 · HET
Birtcher Medical Systems, Inc.
Obstetrics & Gynecology · 385d
Cleared Apr 25, 1994
BUTTRESS PLATE
K931679 · HRS
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
CANNULATED NAVICULAR SCREW
K931681 · HWC
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
CLOVERLEAF PLATE
K931683 · HRS
Onyx Medical Corp.
Orthopedic · 385d
Cleared Apr 25, 1994
FOREARM SELF COMPRESSION PLATE
K931685 · HRS
Onyx Medical Corp.
Orthopedic · 385d