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
75169–75192 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 15, 2002
THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS
K021042 · MQG
Thermo Forma, Inc.
Obstetrics & Gynecology · 44d
Cleared May 15, 2002
FORTAFLEX SURGICAL SLING
K021107 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 40d
Cleared May 15, 2002
UNI-PATCH ULTRASOUND COUPLING GEL
K021132 · MUI
The Ludlow Company LP
Radiology · 36d
Cleared May 15, 2002
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000
K021175 · CAF
Aerogen, Inc.
Anesthesiology · 33d
Cleared May 15, 2002
BIO-LOGIC ABAER CUB
K021215 · GWJ
Bio-Logic Systems Corp.
Neurology · 28d
Cleared May 15, 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK...
K021228 · DQX
Guidant Corp.
Cardiovascular · 27d
Cleared May 15, 2002
SURGASSIST FLEXSHAFT 2, MODEL FS2 14
K021249 · GDW
Power Medical Interventions, Inc.
General & Plastic Surgery · 26d
Cleared May 15, 2002
MODIFICATION TO SPARC SLING SYSTEM
K021263 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 23d
Cleared May 15, 2002
MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057
K021368 · BTA
Medela AG
General & Plastic Surgery · 15d
Cleared May 15, 2002
PHILIPS INFORMATION CENTER SOFTWARE REVISION D.02
K021422 · MHX
Philips Medical Systems
Cardiovascular · 12d
Cleared May 14, 2002
REPROCESSED COMPRESSION LIMB SLEEVES
K012658 · JOW
Surgical Instruments Service and...
Cardiovascular · 274d
Cleared May 14, 2002
BABIES BEST WATER TEETHER / GUM SOOTHER, VARIOUS
K013587 · KKO
Babies Best, Inc.
Dental · 196d
Cleared May 14, 2002
NYCOCARD CRP
K013787 · DCK
Primus Corp.
Chemistry · 181d
Cleared May 14, 2002
MICROJET CRONO PAR AND CRONO APO-GO
K013840 · FRN
Cane S.R.L.
General Hospital · 176d
Cleared May 14, 2002
LATEX SURGEONS GLOVE (POWDERED)
K014278 · KGO
Brightway Gloves Pvt. , Ltd.
General Hospital · 138d
Cleared May 14, 2002
I-STAT PROTHROMBIN TIME TEST
K020355 · GJS
I-Stat Corporation
Hematology · 99d
Cleared May 14, 2002
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
K020489 · JPD
Tosoh Medics, Inc.
Hematology · 90d
Cleared May 14, 2002
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
K020618 · GLK
Aalto Scientific, Ltd.
Hematology · 78d
Cleared May 14, 2002
STERISHARP 3-GALLON RSDC, MODEL RSDC3G
K020664 · MMK
Sterilogic Waste Systems, Inc.
General Hospital · 74d
Cleared May 14, 2002
MS-30 LATERAL FEMORAL STEM
K020713 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 70d
Cleared May 14, 2002
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
K020816 · JIY
Diagnostic Chemicals , Ltd.
Chemistry · 62d
Cleared May 14, 2002
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT
K020823 · DFZ
Sanquin Blood Supply Foundation
Immunology · 61d
Cleared May 14, 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
K021022 · GGN
Instrumentation Laboratory CO
Hematology · 46d
Cleared May 14, 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
K021023 · GGN
Instrumentation Laboratory CO
Hematology · 46d