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

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175,820 results
133009–133032 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 03, 1989
ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT
K884026 · GNA
Oxoid U.S.A., Inc.
Microbiology · 133d
Cleared Feb 03, 1989
TURBOX RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K884180 · DHR
Unipath , Ltd.
Immunology · 126d
Cleared Feb 03, 1989
PF TEST
K884513 · GMZ
Medi-Tech, Inc.
Microbiology · 99d
Cleared Feb 03, 1989
LUMINEB I
K884722 · BTI
Lumiscope Co., Inc.
Anesthesiology · 85d
Cleared Feb 03, 1989
LYTENING 6 SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
K884731 · JFP
Amdev, Inc.
Chemistry · 85d
Cleared Feb 03, 1989
HANDIDAM
K884828 · EIE
Aseptico, Inc.
Dental · 77d
Cleared Feb 03, 1989
BIOFEEDBACK DEVICE TG3, TG4
K884851 · HCC
Moe
Neurology · 77d
Cleared Feb 03, 1989
ELECTRA 900C AUTOMATIC COAGULATION TIMER
K884863 · GKP
Medical Laboratory Automation...
Hematology · 74d
Cleared Feb 03, 1989
IMMUNODOT TORCH TEST RUBELLA
K884898 · LFX
General Biometrics, Inc.
Microbiology · 72d
Cleared Feb 03, 1989
THE BREATHE EASE NURSERY VAPOR TENT
K884922 · FNC
Cal-Trends Products
Anesthesiology · 67d
Cleared Feb 03, 1989
TU SUCTIONTRAP
K884944 · BSY
Tulan Corp. C/O Richard Hamer Assoc.
Anesthesiology · 70d
Cleared Feb 03, 1989
KOAGULAB* 32-S COAGULATION SYSTEM
K885035 · GKP
Ortho Diagnostic Systems, Inc.
Hematology · 60d
Cleared Feb 03, 1989
KODAFLEX II RADIATION THERAPY L CASSETTE
K885178 · IXA
Eastman Kodak Company
Radiology · 51d
Cleared Feb 03, 1989
OLYMPUS ISE MODULE
K885193 · CGZ
Olympus Corp.
Chemistry · 49d
Cleared Feb 03, 1989
PRECISE ILA AND ILAN SURGICAL STAPLES
K885222 · GDW
3M Company
General & Plastic Surgery · 45d
Cleared Feb 03, 1989
MODEL 20-CH CARBON DIOXIDE LASER W/ACCESSORIES
K885291 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 38d
Cleared Feb 03, 1989
WHEELCHAIR, MECHANICAL
K885330 · IOR
Kaye Products, Inc.
Physical Medicine · 37d
Cleared Feb 03, 1989
FACE MASK
K890016 · FXX
Anjudd Intl.
General Hospital · 31d
Cleared Feb 03, 1989
PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)
K890034 · JIY
American Monitor Corp.
Chemistry · 30d
Cleared Feb 03, 1989
SPINETRAK
K890074 · LXJ
Motion Analysis Corp.
Physical Medicine · 25d
Cleared Feb 03, 1989
FOOTTRAK
K890075 · LXJ
Motion Analysis Corp.
Physical Medicine · 25d
Cleared Feb 03, 1989
ORTHOTRAK
K890076 · LXJ
Motion Analysis Corp.
Physical Medicine · 25d
Cleared Feb 03, 1989
MODIFIED LABSYSTEMS' RUBELLA IGG EIA TEST KIT
K890091 · LFX
Labsystems, Inc.
Microbiology · 29d
Cleared Feb 03, 1989
INTRAVASCULAR ADMINISTRATION SET
K890127 · FMI
Multi-Med, Inc.
General Hospital · 22d