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
115345–115368 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 1992
OLYMPUS CHOLESTEROL REAGENT
K922231 · CHH
Olympus Corp.
Chemistry · 190d
Cleared Nov 18, 1992
ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM.
K922423 · GEI
Access Surgical Intl., Inc.
General & Plastic Surgery · 181d
Cleared Nov 18, 1992
BALLOON DILATATION CATHETER
K922610 · LIT
Boston Scientific Corp
Cardiovascular · 169d
Cleared Nov 18, 1992
DISPOSABLE BRONCHOSCOPE BIOPSY FORCEPS
K923847 · EOQ
Wilson-Cook Medical, Inc.
Ear, Nose, Throat · 110d
Cleared Nov 18, 1992
ROCHE REAGENT FOR GGT
K924246 · JQB
Roche Diagnostic Systems, Inc.
Chemistry · 86d
Cleared Nov 18, 1992
INTRODUCER, PERCUTANEOUS -- MODIFICATION
K924491 · DYB
Medamicus, Inc.
Cardiovascular · 90d
Cleared Nov 18, 1992
TSH - THIRD GENERATION LOW CONTROLS
K924675 · JJX
Nichols Institute
Chemistry · 63d
Cleared Nov 18, 1992
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K925156 · CJE
Olympus Corp.
Chemistry · 36d
Cleared Nov 17, 1992
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
K921681 · GGM
Isolab, Inc.
Hematology · 223d
Cleared Nov 17, 1992
PRECI-JET 50
K921797 · KZE
Hmi Industries, Inc.
General Hospital · 217d
Cleared Nov 17, 1992
BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE
K921978 · CAP
Core-M, Inc.
Anesthesiology · 203d
Cleared Nov 17, 1992
USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING
K922105 · DQO
C.R. Bard, Inc.
Cardiovascular · 195d
Cleared Nov 17, 1992
ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM
K922425 · GEI
Access Surgical Intl., Inc.
General & Plastic Surgery · 180d
Cleared Nov 17, 1992
SEEKER LITE - 10
K922912 · DQX
Target Therapeutics
Cardiovascular · 153d
Cleared Nov 17, 1992
LUMICO ANALYZER SA-300
K923158 · JJQ
Maruzen Petrochemical Co., Ltd.
Chemistry · 141d
Cleared Nov 17, 1992
BALDUR LATEX EXAMINATION GLOVES
K923707 · LYY
Hti Trading Group
General Hospital · 113d
Cleared Nov 17, 1992
LATEX EXAMINATION GLOVES
K923772 · LYY
Trico Intl., Inc.
General Hospital · 112d
Cleared Nov 17, 1992
BOBCAT
K923796 · INI
Mobility Mfg. Co.
Physical Medicine · 167d
Cleared Nov 17, 1992
MEGABEAM
K923953 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 103d
Cleared Nov 17, 1992
LC TRAY MATERIAL
K923979 · EBH
Dentsply Intl.
Dental · 103d
Cleared Nov 17, 1992
ORTHO WAX
K924024 · EGD
Heraeus Kulzer, Inc.
Dental · 98d
Cleared Nov 17, 1992
EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA
K924174 · NHJ
J. H. Emerson Co.
Anesthesiology · 90d
Cleared Nov 16, 1992
E-Z-EM ENTEROCLYSIS CATHETER SET
K911349 · EZK
E-Z-Em, Inc.
Gastroenterology & Urology · 600d
Cleared Nov 16, 1992
OXFORD OPTRONIX MPM 3S
K914397 · FTI
Dia-Stron, Ltd.
Gastroenterology & Urology · 412d