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
132409–132432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 06, 1989
HANDLING & CUTTING DEVICE FOR IRIDIUM-192 WIRE PIN
K890191 · IWJ
Amersham Corp.
Radiology · 19d
Cleared Feb 03, 1989
THE BOOSTER
K860698 · LKY
Knapps Corp.
Gastroenterology & Urology · 1074d
Cleared Feb 03, 1989
STERILE & NON-STERILE SURGEONS GLOVES
K882200 · KGO
Taroko Ent., Ltd.
General Hospital · 263d
Cleared Feb 03, 1989
LATEX SURGICAL GLOVE (NON STERILE)
K883556 · KGO
Makintech Corp.
General Hospital · 168d
Cleared Feb 03, 1989
COONRAD III TOTAL ELBOW
K883665 · JDC
Zimmer, Inc.
Orthopedic · 161d
Cleared Feb 03, 1989
COULTER CLONE T3 MONOCLONAL ANTIBODY
K883710 · GKZ
Coulter Immunology
Hematology · 157d
Cleared Feb 03, 1989
COULTER CLONE T1 MONOCLONAL ANTIBODY
K883753 · GKZ
Coulter Immunology
Hematology · 154d
Cleared Feb 03, 1989
BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE
K883776 · LKI
Btc Corp.
Microbiology · 150d
Cleared Feb 03, 1989
RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER
K883845 · DXK
Phoenix Imaging
Cardiovascular · 144d
Cleared Feb 03, 1989
COULTER CLONE B4 MONOCLONAL ANTIBODY
K884020 · GKZ
Coulter Immunology
Hematology · 134d
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