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
133321–133344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 1988
CONCEPT POWER SYSTEM
K881954 · HSZ
Concept, Inc.
Orthopedic · 183d
Cleared Nov 09, 1988
OEC-7102 ECG/NIBP MONITOR
K882254 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 162d
Cleared Nov 09, 1988
ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR
K882635 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 135d
Cleared Nov 09, 1988
TRIAD-EP, PUSHBUTTON, CABLE INPUT TYPE
K883178 · DRO
Cardiotronics, Inc.
Cardiovascular · 105d
Cleared Nov 09, 1988
KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S
K883215 · JWH
Kirschner Medical Corp.
Orthopedic · 103d
Cleared Nov 09, 1988
TRAID-EP, PLATE INPUT, W/PULSE BLANKING CIRCUITRY
K883304 · DRO
Cardiotronics, Inc.
Cardiovascular · 98d
Cleared Nov 09, 1988
CARDIOBEEPER II
K883843 · DXH
Survival Technology, Inc.
Cardiovascular · 58d
Cleared Nov 09, 1988
SEAMED MODEL 3300 DUAL CHAMBER PACING SYSTEM ANALY
K883930 · DTE
Seamed Corp.
Cardiovascular · 55d
Cleared Nov 09, 1988
MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A
K883973 · DXJ
Nihon Kohden America, Inc.
Cardiovascular · 50d
Cleared Nov 09, 1988
MODEL 459 ELECTROCARDIOCORDER RECORDER
K884009 · DSH
Del Mar Avionics
Cardiovascular · 49d
Cleared Nov 09, 1988
SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)
K884465 · CAH
Spirometrics, Inc.
General Hospital · 16d
Cleared Nov 08, 1988
DIMENSION WHOLE BLOOD CHOLESTEROL
K880723 · CHH
Technimed, Inc.
Chemistry · 259d
Cleared Nov 08, 1988
ENVIROTENT (BED)
K881725 · FNJ
Envirotents, Inc.
General Hospital · 200d
Cleared Nov 08, 1988
STERILE SURGICAL LATEX GLOVES
K882715 · KGO
Plastic Materials of Puerto Rico, Inc.
General Hospital · 130d
Cleared Nov 08, 1988
ALCON FLUID INJECTOR
K882723 · DQF
Alcon Laboratories
General Hospital · 130d
Cleared Nov 08, 1988
VKG 1000, VIDEO KERATOMETER
K883471 · HLP
Technitex, Inc.
Ophthalmic · 84d
Cleared Nov 08, 1988
BIOSEARCH 3600 ENTRI FEEDING PUMP
K883587 · FRN
Biosearch Medical Products, Inc.
General Hospital · 77d
Cleared Nov 08, 1988
SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)
K884196 · HRQ
Disposable Sterile Surgical...
General & Plastic Surgery · 35d
Cleared Nov 08, 1988
CONCEPT CCT-5200, THERMAL THERAPY SYSTEM
K884255 · ILO
Concept, Inc.
Physical Medicine · 28d
Cleared Nov 08, 1988
SURGICAL APPAREL, ISOLATION GOWN,MASK,CAP,SLEEVE
K884295 · LGM
Saybrex Intl., Inc.
General Hospital · 27d
Cleared Nov 08, 1988
KORBER ARTERIOTOMY SCISSORS
K884373 · LRW
Micrins, Ltd.
General & Plastic Surgery · 21d
Cleared Nov 08, 1988
BED SHEET, PILLOW CASE
K884380 · KME
Saybrex Intl., Inc.
General Hospital · 21d
Cleared Nov 08, 1988
HERNIASTAT
K884404 · GAG
Innovative Surgical Devices Corp.
General & Plastic Surgery · 20d
Cleared Nov 08, 1988
RESUBMITTED 1,3 & 4 WAY STOPCOCKS, VARIOUS PARTS
K884435 · FMG
Clinical Connections, Inc.
General Hospital · 26d