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
131353–131376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 24, 1989
SUCTION CONTROL VALVE
K892343 · BSY
Concord/Portex
Anesthesiology · 19d
Cleared Apr 21, 1989
COOK-GIANTURCO BILIARY Z STENT
K882610 · FGE
Cook, Inc.
Gastroenterology & Urology · 301d
Cleared Apr 21, 1989
MODIFIED NUMED BALLOON ANGIOGRAPHIC CATHETER
K883948 · DYG
NuMED, Inc.
Cardiovascular · 220d
Cleared Apr 21, 1989
IMAGER FLUSH CATHETERS
K884354 · DQO
Medi-Tech, Inc.
Cardiovascular · 186d
Cleared Apr 21, 1989
BERICHROM ALPHA-2-ANTIPLASMIN
K884797 · GGP
Behring Diagnostics, Inc.
Hematology · 156d
Cleared Apr 21, 1989
RETRACTABLE PISTON SYRINGE W/LUER-LOCK COLLAR
K884841 · FMF
Hall Medical Laboratories
General Hospital · 151d
Cleared Apr 21, 1989
KAMED STETHOSCOPE
K890126 · LDE
D.R.G.
Cardiovascular · 99d
Cleared Apr 21, 1989
FTK FECAL TRANSPORT KIT
K890134 · LIO
Evergreen Scientific, Inc.
Microbiology · 98d
Cleared Apr 21, 1989
GOLDEN MEAN MACHINE(TM) (CLASS 2)
K890401 · ISD
Bennett Ergonomic Labs, Inc.
Physical Medicine · 87d
Cleared Apr 21, 1989
SIGMOID TONOMITOR
K890466 · GBT
Tonometrics, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 21, 1989
HI-LO TEMP GENERAL PURPOSE TEMPERATURE PROBE
K890484 · FLL
Mallinckrodt Anesthesia Products
General Hospital · 80d
Cleared Apr 21, 1989
SINGLE LUMEN S.E.A.-PORT VASCULAR ACCESS SYSTEM
K890518 · LJT
Harbor Medical Devices, Inc.
General Hospital · 78d
Cleared Apr 21, 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · BZG
Puritan Bennett Corp.
Anesthesiology · 78d
Cleared Apr 21, 1989
ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS
K890527 · DTB
Medtronic Vascular
Cardiovascular · 78d
Cleared Apr 21, 1989
ENZYGNOST PLATELET FACTOR 4 (PF4) KIT
K890633 · LCO
Behring Diagnostics, Inc.
Hematology · 72d
Cleared Apr 21, 1989
BERICHROM PROTEIN C KIT
K890634 · GGP
Behring Diagnostics, Inc.
Hematology · 72d
Cleared Apr 21, 1989
ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT
K890751 · FOZ
Medical Safety Products, Inc.
General Hospital · 67d
Cleared Apr 21, 1989
INFRALASE - LASERGUIDE DELIVERY SYSTEM
K890775 · GEX
Ximed Medical Systems
General & Plastic Surgery · 65d
Cleared Apr 21, 1989
EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME
K890859 · GFO
Elite Diagnostic , Ltd.
Hematology · 59d
Cleared Apr 21, 1989
INTRAVASCULAR ADMINISTRATION SET
K891072 · FPA
Multi-Med, Inc.
General Hospital · 51d
Cleared Apr 21, 1989
THROMBOSCREEN APTT REAGENT
K891337 · GFO
Pacific Hemostasis
Hematology · 42d
Cleared Apr 21, 1989
EDL ONE-STAGE PROTHROMBIN TIME REAGENT
K891370 · GJS
Elite Diagnostic , Ltd.
Hematology · 43d
Cleared Apr 21, 1989
LIQUICHEK(R) SERUM ALCOHOL CONTROL
K892004 · LAS
Bio-Rad
Chemistry · 24d
Cleared Apr 21, 1989
V-TREND TARGET CRP TEST
K892231 · DCN
Texas Immunology, Inc.
Immunology · 17d