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
129841–129864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1989
IFA SENSIBAC VANCOMYCIN
K892725 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC INIPENEM
K892727 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC TOBRAMYCIN
K892729 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
IFA SENSIBAC CHLROAMPHENICOL
K892730 · JTN
Investigacion Farmaceutica S.A. DE C.V.
Microbiology · 111d
Cleared Aug 03, 1989
MG II POROUS TOTAL KNEE SYSTEM
K892800 · JWH
Zimmer, Inc.
Orthopedic · 108d
Cleared Aug 03, 1989
PRECIOUS LITE MODEL 4224
K892940 · LBI
E & B Technologies, Inc.
General Hospital · 104d
Cleared Aug 03, 1989
LATEX EXAM GLOVES
K892971 · LYY
P.C. Commercial, Inc.
General Hospital · 113d
Cleared Aug 03, 1989
PATIENT EXAMINATION GLOVES
K892981 · LYY
Lapoma Gloves Industries Sdn. Bhd.
General Hospital · 113d
Cleared Aug 03, 1989
PATIENT LATEX EXAMINATION GLOVES
K892982 · LYY
Ataro Industri (Malaysia) Sdn Bhd
General Hospital · 113d
Cleared Aug 03, 1989
APACERAM OSSICULAR PROSTHESIS
K893134 · ETB
Asahi Optical Co. C/O Rosati...
Ear, Nose, Throat · 100d
Cleared Aug 03, 1989
LATEX EXAMINATION GLOVES
K893264 · LYY
P.T. Kreasi Bhojwanis
General Hospital · 78d
Cleared Aug 03, 1989
MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE
K893403 · LDD
Hewlett-Packard Co.
Cardiovascular · 94d
Cleared Aug 03, 1989
INTEGRA(TM) BLOOD GLUCOSE MONITORING SYSTEM
K893404 · CGA
Apprise, Inc.
Chemistry · 93d
Cleared Aug 03, 1989
COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM)
K893419 · DEW
Coulter Immunology
Microbiology · 93d
Cleared Aug 03, 1989
SIEMENS SAO2 + PULS OXIMETRY CARTRIDGE
K893470 · DQA
Siemens Medical Electronics
Anesthesiology · 91d
Cleared Aug 03, 1989
CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER
K893547 · JJE
Heraeus Kulzer, Inc.
Chemistry · 87d
Cleared Aug 03, 1989
SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP
K893548 · LBS
Heraeus Kulzer, Inc.
Chemistry · 87d
Cleared Aug 03, 1989
STATUS HCG FLUOROMETRIC ENZYME
K893577 · DHA
Baxter Healthcare Corp
Chemistry · 86d
Cleared Aug 03, 1989
GAMMA LOCKING NAIL
K893639 · KTT
Howmedica Corp.
Orthopedic · 83d
Cleared Aug 03, 1989
PERCUTANEOUS INTRODUCER
K893658 · DYB
Medamicus, Inc.
Cardiovascular · 80d
Cleared Aug 03, 1989
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · DTL
3M Company
Cardiovascular · 79d
Cleared Aug 03, 1989
ETHICON DISPOSABLE SURGICAL TROCAR
K893715 · HET
Ethicon, Inc.
Obstetrics & Gynecology · 77d
Cleared Aug 03, 1989
ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER
K893776 · JJE
Abbott Laboratories
Chemistry · 73d
Cleared Aug 03, 1989
IMMUNO-WASH AUTOMATED TUBE WASHER
K893810 · JQW
Ocean Scientific, Inc.
Chemistry · 73d