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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
135385–135408 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1988
ATS CRYPTOSPORIDIUM STAIN SET
K880989 · JTS
Alpha-Tec Systems, Inc.
Pathology · 66d
Cleared May 13, 1988
FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
K880996 · GQN
Whittaker Bioproducts, Inc.
Microbiology · 66d
Cleared May 13, 1988
MENTOR WET-FIELD*II COAGULATOR
K881001 · HQQ
Mentor O & O, Inc.
Ophthalmic · 65d
Cleared May 13, 1988
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
K881011 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 64d
Cleared May 13, 1988
SUPER PIK MASSAGING PICK FOR ORAL HYGIENE
K881046 · JET
U.S. Dentek Corp.
Dental · 63d
Cleared May 13, 1988
FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG
K881180 · GQN
Whittaker Bioproducts, Inc.
Microbiology · 66d
Cleared May 13, 1988
MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
K881186 · GHY
Helps Products, Inc.
Hematology · 53d
Cleared May 13, 1988
ADVANCE DIAGNOSTICS DISPOSABLE EYECUP
K881369 · LXQ
Advantage Diagnostics Corp.
Ophthalmic · 42d
Cleared May 13, 1988
WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
K881592 · KPA
Wescor, Inc.
Pathology · 31d
Cleared May 13, 1988
AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID
K881653 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 28d
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