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
144745–144768 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1986
AM 31, HEARING AID
K860008 · ESD
Electone, Inc.
Ear, Nose, Throat · 68d
Cleared Mar 12, 1986
DENPAX
K860058 · EBR
Nissho Iwai American Corp.
Dental · 65d
Cleared Mar 12, 1986
A & M DISCREET - HEARING AID
K860190 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 12, 1986
PA PRESIDENTIAL II - HEARING AID
K860191 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 12, 1986
A & M 150 PP (HEARING AID)
K860244 · ESD
Electone, Inc.
Ear, Nose, Throat · 47d
Cleared Mar 12, 1986
ENTROKIT WITH MAGLINTE CATHETER
K860441 · KGC
Lafayette Pharmacal, Inc.
Gastroenterology & Urology · 36d
Cleared Mar 12, 1986
GIBCO MYCOTECT KIT (CATALOG NO. 189-5672)
K860695 · KIW
Gibco Laboratories Life Technologies,...
Microbiology · 15d
Cleared Mar 12, 1986
MICRO CARRIER
K860783 · KIT
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
DULBECCO'S PHOSPHATE BUFFERED SALINE W/CALCL2
K860784 · KIP
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
HAM'S F-12 W/NAHCO3
K860785 · KIT
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
RPMI 1640 HEPES
K860786 · KIT
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
DULBECCO'S MEM
K860787 · KIT
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
HAM'S F-12 W/GLUTAMINE & NAHCO3
K860788 · KIT
Tissue Culture Innovations
Pathology · 9d
Cleared Mar 12, 1986
SPOTTEST CALCOFLUOR WHITE REAGENT
K860795 · LED
Difco Laboratories, Inc.
Pathology · 8d
Cleared Mar 11, 1986
PATIENT MONITOR PB240
K853318 · DRT
Puritan Bennett Corp.
Cardiovascular · 216d
Cleared Mar 11, 1986
HARD CONTACT LENS CLEANING & SOAKING SOLUTION
K853808 · HPX
Maurry Biological Co.
Ophthalmic · 181d
Cleared Mar 11, 1986
DAILY HARD CONTACT LENS CLEANER
K853809 · HPX
Maurry Biological Co.
Ophthalmic · 181d
Cleared Mar 11, 1986
RESPIRATORY RESUSCITATION DEVICE
K854029 · CAE
John H. Harrison
Anesthesiology · 161d
Cleared Mar 11, 1986
SIRECUST 341 AND 341R
K854881 · DRT
Siemens Medical Solutions USA, Inc.
Cardiovascular · 95d
Cleared Mar 11, 1986
MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD
K854917 · DTB
Intermedics, Inc.
Cardiovascular · 92d
Cleared Mar 11, 1986
MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD
K854918 · DTB
Intermedics, Inc.
Cardiovascular · 92d
Cleared Mar 11, 1986
OXOID STREPTOCOCAL GROUPING KIT
K854929 · GTZ
Oxoid U.S.A., Inc.
Microbiology · 91d
Cleared Mar 11, 1986
AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
K855034 · LIJ
Bartels Immunodiagnostic Supplies, Inc.
Pathology · 84d
Cleared Mar 11, 1986
ANGIOMED URETER DIATION SETS
K855076 · KOD
Angiomed U.S., Inc.
Gastroenterology & Urology · 82d