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
132169–132192 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1989
EXTEND INTENDED USE FOR ENZYME RINSE CONCENTRATE
K890990 · CHH
Hichem Diagnostics
Chemistry · 42d
Cleared Apr 10, 1989
VENTREX COATED TUBE T3 UPTAKE
K891068 · KHQ
Ventrex Laboratories, Inc.
Chemistry · 40d
Cleared Apr 10, 1989
HDL CHOLESTEROL REAGENT
K891117 · LBR
Pointe Scientific, Inc.,
Chemistry · 39d
Cleared Apr 10, 1989
DADE THROMBOPLASTIN IS
K891169 · GJS
Baxter Healthcare Corp
Hematology · 35d
Cleared Apr 10, 1989
EDL ABNORMAL COAGULATION CONTROL
K891175 · GGL
Elite Diagnostic , Ltd.
Hematology · 35d
Cleared Apr 10, 1989
EDL NORMAL COAGULATION CONTROL
K891179 · GIZ
Elite Diagnostic , Ltd.
Hematology · 35d
Cleared Apr 10, 1989
BIOTROL CHEMISTRY URINE CONTROL
K891286 · JJW
Biotrol, USA, Inc.
Chemistry · 32d
Cleared Apr 10, 1989
PM830 ELECTRIC MASSAGER
K891394 · ISA
Back IN Action, Inc.
Physical Medicine · 27d
Cleared Apr 07, 1989
PERFECTA II/NON-COATED TOTAL HIP SYSTEM
K884027 · JDI
Orthomet, Inc.
Orthopedic · 196d
Cleared Apr 07, 1989
OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT
K890197 · KWZ
Osteonics Corp.
Orthopedic · 80d
Cleared Apr 07, 1989
AIDE-A-PATIENT (NURSING HOME BED)
K890293 · FNL
Morton Metalcraft Co.
General Hospital · 78d
Cleared Apr 07, 1989
ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY
K890463 · HIO
Critical Specialties, Inc.
Obstetrics & Gynecology · 67d
Cleared Apr 07, 1989
ABSORBENT GAUZE ROLL
K890672 · NAB
Smith & Nephew United, Inc.
General & Plastic Surgery · 57d
Cleared Apr 07, 1989
MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP
K890941 · GDO
United States Surgical, A Division of...
General & Plastic Surgery · 43d
Cleared Apr 07, 1989
SPECBOARD
K891090 · IZH
Macbrud Corp. Medical Div.
Radiology · 32d
Cleared Apr 07, 1989
SODIUM BICARBONATE, U.S.P.
K891159 · KPO
Williams Medical Co.
Gastroenterology & Urology · 32d
Cleared Apr 07, 1989
BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET
K891406 · LJE
Cook Urological, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 07, 1989
PRECEPT MICRO-GARD LASER MASK
K891409 · FXX
Mars White Knight
General Hospital · 24d
Cleared Apr 07, 1989
C-52 GOLD BASE DENTAL ALLOY
K891515 · EJT
Macdonald Metals and Ceramics
Dental · 21d
Cleared Apr 07, 1989
M-56 GOLD BASE DENTAL ALLOY
K891526 · EJT
Macdonald Metals and Ceramics
Dental · 21d
Cleared Apr 07, 1989
ORTHODONTIC ARCH AND SURGICAL HOOKS
K891592 · EJF
American Orthodontics
Dental · 18d
Cleared Apr 07, 1989
GOLD CLASS, GRANDTEX, LATEX EXAMINATION GLOVES
K891648 · LYY
Harry Panzer Intl. Corp.
General Hospital · 21d
Cleared Apr 07, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891743 · LYY
Dispotex Industries Sdn. Bhd.
General Hospital · 16d
Cleared Apr 07, 1989
DA-46 FLUID BARRIER
K891752 · FIB
Akcess Medical Products, Inc.
Gastroenterology & Urology · 15d