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
141577–141600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 1986
SPAND-GEL GRANULATED GEL
K864124 · KMF
Medi-Tech Intl. Corp.
General & Plastic Surgery · 36d
Cleared Nov 26, 1986
MICROSELECTRON-HDR (HIGH DOSE RATE)
K864210 · JAQ
Nucletron-Oldelft Corp.
Radiology · 29d
Cleared Nov 26, 1986
VERINOR ALLOY
K864306 · EJT
Degussa Dental, Inc.
Dental · 23d
Cleared Nov 26, 1986
STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)
K864311 · FYA
Clinitech, Inc.
General Hospital · 23d
Cleared Nov 26, 1986
RAYLOR(TM) PERIOSTEAL ELEVATORS
K864421 · GEG
Cedar Surgical, Inc.
General & Plastic Surgery · 16d
Cleared Nov 26, 1986
RAYLOR(TM) PROTECTIVE RETRACTOR
K864424 · GAD
Cedar Surgical, Inc.
General & Plastic Surgery · 16d
Cleared Nov 26, 1986
RAYLOR(TM) DEPTH GAUGE
K864426 · HTJ
Cedar Surgical, Inc.
Orthopedic · 16d
Cleared Nov 26, 1986
DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC
K864474 · EHD
Planmeca USA, Inc.
Radiology · 13d
Cleared Nov 25, 1986
MEDA 2500 T.E.N.S.
K862450 · GZJ
Watlow/Winona, Inc.
Neurology · 151d
Cleared Nov 25, 1986
MUSCLE MASTER (BIPOLAR STIMULATOR)
K862685 · IPF
Modern Systems Technology, Inc.
Physical Medicine · 133d
Cleared Nov 25, 1986
TRAVELER LT
K862690 · GWF
Bio-Logic Systems Corp.
Neurology · 133d
Cleared Nov 25, 1986
7.5 MHZ LINEAR PROBE, CAT. NO. H4221H
K862844 · ITX
General Electric Co.
Radiology · 119d
Cleared Nov 25, 1986
D200 ADVANCED COMPUTER CARDIAC ANALYSIS SYSTEM
K863230 · DXG
Dextra Medical, Inc.
Cardiovascular · 96d
Cleared Nov 25, 1986
D100 COMPUTER CARDIAC ANALYSIS SYSTEM
K863231 · DXG
Dextra Medical, Inc.
Cardiovascular · 96d
Cleared Nov 25, 1986
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
K863476 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 77d
Cleared Nov 25, 1986
DERMATEC ZONE TRANSPARENT DRESSING
K863578 · NAD
Dermatec, Inc.
General & Plastic Surgery · 89d
Cleared Nov 25, 1986
ESOPHAGEAL RECTAL TEMPERATURE PROBE
K863646 · FLL
Respiratory Support Products, Inc.
General Hospital · 68d
Cleared Nov 25, 1986
STERILIZATION WRAPS #620,624,648,640,636,630,612
K863981 · FRG
Graham Medical Products
General Hospital · 42d
Cleared Nov 25, 1986
EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95
K864041 · KLS
Em Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Nov 25, 1986
ANAGO ISOLATION MASK (#80-950)
K864116 · LGM
Anago, Inc.
General Hospital · 35d
Cleared Nov 25, 1986
IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY
K864213 · LGP
Instrumentation Laboratory CO
Hematology · 28d
Cleared Nov 25, 1986
IL TEST 97574-15M, ANTITTHROMBIN III ASSASY
K864214 · JBQ
Instrumentation Laboratory CO
Hematology · 28d
Cleared Nov 25, 1986
IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA
K864271 · JPA
Instrumentation Laboratory CO
Hematology · 27d
Cleared Nov 25, 1986
OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE
K864372
Osteonics Corp.
Orthopedic · 20d