FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
133921–133944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 07, 1988
IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER
K882138 · DPW
Imex Medical Systems, Inc.
Cardiovascular · 171d
Cleared Nov 07, 1988
STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY
K882875 · IZH
Lorad Medical Systems, Inc.
Radiology · 119d
Cleared Nov 07, 1988
DITTMAR POWER LIFTER
K883260 · FOX
Dittmar and Penn Corp.
General Hospital · 96d
Cleared Nov 07, 1988
OPTIMED ADVANTAGE
K883458 · HPT
Optimed, Inc.
Ophthalmic · 87d
Cleared Nov 07, 1988
THERMOMETER, MERCURY/CLINICAL
K883573 · FLK
Umax Corp.
General Hospital · 77d
Cleared Nov 07, 1988
LUM VASCULAR PROCEDURE SYSTEM #B5200A
K883664 · IYB
General Electric Co.
Radiology · 73d
Cleared Nov 07, 1988
REUSABLE ADULT INCONTINENT DIAPER
K883787 · EYQ
Intera Corp.
Gastroenterology & Urology · 61d
Cleared Nov 07, 1988
ERGO II, SURGICAL LATEX GLOVES
K884030 · KGO
Ergo Intl., Ent., Inc.
General Hospital · 45d
Cleared Nov 07, 1988
CRITICAL CARE I.V. STAND STABILIZING BRACKET
K884341 · FOX
Rbd Medical, Inc.
General Hospital · 24d
Cleared Nov 07, 1988
CMS IV EXTENSION SETS
K884370 · FPK
Churchill Medical Systems, Inc.
General Hospital · 20d