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
131065–131088 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1989
ALPHA MODEL I ITE HEARING AID
K890271 · ESD
Alpha Instruments, Inc.
Ear, Nose, Throat · 149d
Cleared Jun 16, 1989
MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
K890323 · DSI
Marquette Electronics, Inc.
Cardiovascular · 144d
Cleared Jun 16, 1989
IMPLANT PARALLELING DEVICE (I.P.D.)
K890433 · EFB
J.E. Josephson, D.M.D.
Dental · 140d
Cleared Jun 16, 1989
ADEL - MODEL 986 INFANT WARMER
K890476 · FMZ
Adel Medical , Ltd.
General Hospital · 136d
Cleared Jun 16, 1989
STERILE IRRIGATION TRAYS
K890728 · KYZ
Cypress Medical Products, Ltd.
General Hospital · 123d
Cleared Jun 16, 1989
VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M
K891095 · DHA
Leeco Diagnostics, Inc.
Chemistry · 106d
Cleared Jun 16, 1989
VIS-DISK HCG (EIA) JPL-041M
K891096 · DHA
Leeco Diagnostics, Inc.
Chemistry · 106d
Cleared Jun 16, 1989
PRIMUS MODEL CLC 330
K891235 · LCP
Primus, Inc.
Hematology · 101d
Cleared Jun 16, 1989
MICROTRAK EIA AUTOREADER
K891270 · JJQ
Syva Co.
Chemistry · 99d
Cleared Jun 16, 1989
THE CEN-SLIDE(TM) CENTRIFUGE TUBE
K891604 · KEW
Davstar California, Inc.
Pathology · 88d
Cleared Jun 16, 1989
PUL-TRON 100K PROFESSIONAL SPIROMETER
K891672 · BZG
Advanced Medical Systems, Inc.
Anesthesiology · 87d
Cleared Jun 16, 1989
THE SMILE MACHINE
K891694 · JEQ
Brilliant Industries, Inc.
Dental · 86d
Cleared Jun 16, 1989
AMRESCO CHOLESTEROL REAGENTS, PROD. # 7325
K891922 · CHH
American Research Products Co.
Chemistry · 81d
Cleared Jun 16, 1989
DEX-CELL HYSTEROSCOPY FLUID DELIVERY DEVICE
K892001 · HIG
Dexide, Inc.
Obstetrics & Gynecology · 80d
Cleared Jun 16, 1989
SPIRO-LINK REAL TIME SPIROMETRY SYSTEM
K892121 · BZC
Biocom Intl., Inc.
Anesthesiology · 77d
Cleared Jun 16, 1989
D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN
K892224 · KHQ
Photec Diagnostics, Inc.
Chemistry · 74d
Cleared Jun 16, 1989
JESBERG ESOPHAGOSCOPE
K892259 · EOX
Zinnanti Surgical Instruments, Inc.
Ear, Nose, Throat · 73d
Cleared Jun 16, 1989
THE TONGUE CLEANER
K892388 · LCN
Rajiv R. Shah
Dental · 70d
Cleared Jun 16, 1989
NPG 2 BASE METAL ALLOY
K892419 · EJF
Aalba Dent, Inc.
Dental · 67d
Cleared Jun 16, 1989
PALASEAL(R)
K892452 · EBI
Kulzer, Inc.
Dental · 67d
Cleared Jun 16, 1989
KULZER INLAY SYSTEM
K892454 · EBF
Kulzer, Inc.
Dental · 67d
Cleared Jun 16, 1989
IRON SYSTEM PACK REAGENTS
K892838 · JIY
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Jun 16, 1989
GLUCOMETER QA BLOOD GLUCOSE MTR/GLUCOFILM TEST ST
K893117 · CGA
Bayer Corp.
Chemistry · 52d
Cleared Jun 16, 1989
BECKMAN EPSILON(TM) IGE REAGENT KIT
K893125 · DGO
Beckman Instruments, Inc.
Immunology · 52d