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

Filters: Cleared only ×
175,820 results
135985–136008 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1988
MVR/STILETTO BLADE 20GA. - P/N 1900
K881669 · HNN
Advanced Surgical Products, Inc.
Ophthalmic · 25d
Cleared May 13, 1988
ATS PVA FIXATIVE SOLUTION
K881698 · LDZ
Alpha-Tec Systems, Inc.
Pathology · 24d
Cleared May 13, 1988
BREAST LOCALIZATION NEEDLES
K881730 · GDM
Hart Enterprises, Inc.
General & Plastic Surgery · 21d
Cleared May 13, 1988
AUDIOTONE MODEL AVATAR IN-THE-EAR HEARING AID
K881737 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 21d
Cleared May 13, 1988
AUDIOTONE MODEL TLC SECRET IN-THE-EAR HEARING AID
K881738 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 21d
Cleared May 13, 1988
ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42
K881879 · JSK
Alpha-Tec Systems, Inc.
Pathology · 9d
Cleared May 13, 1988
SHARPLAN 719Y MICROSLAD(TM)
K881887 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 8d
Cleared May 12, 1988
CARDIOBEEPER(R) III
K880300 · DXH
Survival Technology, Inc.
Cardiovascular · 108d
Cleared May 12, 1988
DRI-CLAVE LIQUID KLEENZALL
K880754 · EHZ
Columbus Dental Mfg. Co.
Dental · 77d
Cleared May 12, 1988
HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG
K880780 · DRL
First Medical Devices Corp.
Cardiovascular · 76d
Cleared May 12, 1988
OLYMPUS-KEYMED ENDOSCOPIC CO2 REGULATOR, MODEL ECR
K881004 · FCX
Keymed, Inc.
Gastroenterology & Urology · 64d
Cleared May 11, 1988
MARSH ELDER ALLERGEN DISC
K874540 · DHB
Incstar Corp.
Immunology · 190d
Cleared May 11, 1988
SIM MODULE
K874546 · FRN
Critikon Company, LLC
General Hospital · 190d
Cleared May 11, 1988
INNOVATIVE IMPLANTS AND COVER SCREWS
K874590 · DZE
Implant Innovations International, Inc.
Dental · 184d
Cleared May 11, 1988
ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.
K874861 · DPT
Acuson Computed Sonography
Cardiovascular · 166d
Cleared May 11, 1988
WALNUT ALLERGEN DISC
K874883 · DHB
Incstar Corp.
Immunology · 162d
Cleared May 11, 1988
ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE
K875251 · IYO
Philips Medical Systems (Cleveland),...
Radiology · 141d
Cleared May 11, 1988
BIONICA MDS 110 PCA
K875316 · FRN
Bionica, Inc.
General Hospital · 134d
Cleared May 11, 1988
INCSTAR'S BIRCH ALLERGEN DISC
K880168 · DHB
Incstar Corp.
Immunology · 117d
Cleared May 11, 1988
INCSTAR'S PIGWEED ALLERGEN DISC
K880221 · DHB
Incstar Corp.
Immunology · 112d
Cleared May 11, 1988
PALLADIUM-BASED DENTAL ALLOYS FOR PORCELAIN APPLI.
K880348 · EJT
J.F. Jelenko & Co., Inc.
Dental · 106d
Cleared May 11, 1988
ROTA-DENT TOOTH CLEANER
K880589 · JEQ
Pro-Dentec
Dental · 90d
Cleared May 11, 1988
SHILEY BCD PLUS HEAT EXCHANGER
K880663 · DTR
Shiley, Inc.
Cardiovascular · 83d
Cleared May 11, 1988
XR PRIMER
K880684 · KLE
Kerr Corporation (Danbury)
Dental · 82d