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
162073–162096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1981
NUCLEAR ANTIGENS
K810592 · LLL
Alpha Antigens, Inc.
Immunology · 232d
Cleared Oct 23, 1981
AVI-D CONTROL
K811713 · KSF
Ortho Diagnostic Systems, Inc.
Hematology · 128d
Cleared Oct 23, 1981
PORTABLE OXYGEN GENERATOR
K812282 · CAW
American Marketing Assoc., Inc.
Anesthesiology · 71d
Cleared Oct 23, 1981
AUTOTRANS BT795
K812292 · CAC
Electromedics, Inc.
Anesthesiology · 71d
Cleared Oct 23, 1981
HELENA COLOSCREEN METHOD
K812428 · KHE
Helena Laboratories
Hematology · 59d
Cleared Oct 23, 1981
SUCKER CARDIOTOMY RETURN, C.P. BYPASS
K812455 · DTN
Electromedics, Inc.
Cardiovascular · 56d
Cleared Oct 23, 1981
CELL CULTURE REAGENTS
K812531 · KIT
M.A. Bioproducts
Microbiology · 51d
Cleared Oct 23, 1981
ZEE LIFE SUPPORT AIR PANTS
K812564 · LHX
Zee Medical Products Co., Inc.
Anesthesiology · 45d
Cleared Oct 23, 1981
ELUTION SOLUTION
K812565 · KSG
Biological Corp. of America
Immunology · 44d
Cleared Oct 23, 1981
SPIROMETER FILTER
K812573 · CAH
K & G Healthcare Ind., Inc.
General Hospital · 44d
Cleared Oct 23, 1981
MEDTRONIC #4951
K812599 · DTB
Medtronic Vascular
Cardiovascular · 39d
Cleared Oct 23, 1981
INJECTION CAP, LUER LOCK
K812657 · FPA
Procedure Products, Inc.
General Hospital · 35d
Cleared Oct 23, 1981
MEDDARS/ULTRA IMAGER RESPIRATION MODULE
K812667 · BZQ
Honeywell, Inc.
Anesthesiology · 32d
Cleared Oct 23, 1981
FILES & REAMERS
K812692 · EKS
Miltex Instrument Co.
Dental · 31d
Cleared Oct 23, 1981
MODEL 9408 A TELETRACE
K812703 · DXH
Medtronic Vascular
Cardiovascular · 31d
Cleared Oct 23, 1981
STERILE DENTAL ROLL
K812709 · EFN
Medspec Corp.
Dental · 29d
Cleared Oct 23, 1981
SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE
K812730 · JSG
Hoffmann-La Roche, Inc.
Microbiology · 25d
Cleared Oct 23, 1981
RAIN-X
K812737 · BZO
Nova-Ventrx
Anesthesiology · 24d
Cleared Oct 23, 1981
REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
K812741 · LHK
Nolan Biological Laboratories, Inc.
Microbiology · 24d
Cleared Oct 23, 1981
ARGYLE SUCTION CATHETERS
K812747 · BSY
Sherwood Medical Co.
Anesthesiology · 24d
Cleared Oct 23, 1981
MONOJECT M535 35CC SYRINGE
K812748 · FMF
Sherwood Medical Co.
General Hospital · 24d
Cleared Oct 23, 1981
BENNETT VOLUME VENTILATOR CIRCUIT
K812773 · BZO
Ideal Medical, Inc.
Anesthesiology · 18d
Cleared Oct 23, 1981
VENTILATOR CIRCUIT
K812774 · BZO
Hudson Oxygen Therapy Sales Co.
Anesthesiology · 18d
Cleared Oct 23, 1981
DISPENSER ASPIRATOR DA 300
K812782 · JQW
Pharmacia, Inc.
Immunology · 18d