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
131569–131592 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 1989
BORRELIA BURGDORFERI POLYVALENT IGG/IGM ANTIBODY
K885290 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI IGG ANTIBODY TEST SYSTEM
K885293 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
BORRELIA BURGDORFERI IGM ANTIBODY TEST SYSTEM
K885294 · LSR
Medical Diagnostic Technologies, Inc.
Microbiology · 104d
Cleared Apr 10, 1989
PLEUR-EVAC(R) A-8020--INFANT CHEST DRAINAGE SYSTEM
K890129 · GCX
Deknatel, Inc.
General Hospital · 88d
Cleared Apr 10, 1989
PRE-MOISTENED CLEANSING PAD
K890514 · LKB
Bausch & Lomb, Inc.
General Hospital · 68d
Cleared Apr 10, 1989
HI CHEM CALCIUM REAGENT #88808
K890584 · CJY
Hichem Diagnostics
Chemistry · 63d
Cleared Apr 10, 1989
HI-RIDER WHEELCHAIR
K890695 · IPL
Retec USA, Inc.
Physical Medicine · 59d
Cleared Apr 10, 1989
ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55)
K890698 · CKA
Abbott Laboratories
Chemistry · 59d
Cleared Apr 10, 1989
PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIAL
K890707 · DWS
Dlp, Inc.
Cardiovascular · 59d
Cleared Apr 10, 1989
SHAPE-ACTIO METAL TOXICOLOGY CONTROL
K890721 · DIE
Actio, Inc.
Toxicology · 56d
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