FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94153–94176 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 01, 1997
SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 681518
K971266 · FPA
Faulding Medical Device Co.
General Hospital · 27d
Cleared Apr 30, 1997
COBE CENTRYSYSTEM 14 PES HEMODIALYZERS
K955592 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 510d
Cleared Apr 30, 1997
PERMOBIL CHAIRMAN L/CS 8
K960951 · ITI
Permobil AB
Physical Medicine · 415d
Cleared Apr 30, 1997
CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM
K962788 · IKZ
Gaymar Industries, Inc.
Physical Medicine · 287d
Cleared Apr 30, 1997
MD-1A GALVANIC UNIT
K964208 · EGJ
R. A. Fischer Co. Corp.
Physical Medicine · 208d
Cleared Apr 30, 1997
TUNA 5 CATHETER
K965199 · GEI
Vidamed, Inc.
General & Plastic Surgery · 125d
Cleared Apr 30, 1997
TEFGEN - LS
K965205 · NPK
American Custom Medical, Inc.
Dental · 125d
Cleared Apr 30, 1997
AURA TEK FDP
K970353 · MMW
Perimmune, Inc.
Immunology · 90d
Cleared Apr 30, 1997
STRYKER 2115 REPLACEMENT BATTERY (2115)
K970378 · KIJ
Implant Resource, Inc.
Orthopedic · 89d
Cleared Apr 30, 1997
INNOVASIVE ROCLET BONE TUNNEL AUGMENTATION DEVICE
K970423 · MBI
Innovasive Devices, Inc.
Orthopedic · 85d
Cleared Apr 30, 1997
TARGET VITAL-PORT VASCULAR ACCESS SYSTEM
K970442 · LJT
Med Institute, Inc.
General Hospital · 84d
Cleared Apr 30, 1997
IMPLEX BIPOLAR HIP SYSTEM
K970447 · KWY
Implex Corp.
Orthopedic · 83d
Cleared Apr 30, 1997
PCM 2000
K970448 · MSH
Tecnol Medical Products, Inc.
General Hospital · 83d
Cleared Apr 30, 1997
HYFRECATOR 2000
K970493 · GEI
Aspen Labs
General & Plastic Surgery · 79d
Cleared Apr 30, 1997
NATURAL-KNEE II REVISION FEMORAL SPACER LUGS
K970498 · JWH
Intermedics Orthopedics
Orthopedic · 79d
Cleared Apr 30, 1997
3M SUSTEL DENTAL SYSTEM
K970500 · EBF
3M Company
Dental · 79d
Cleared Apr 30, 1997
PEGGED ACETABULAR COMPONENT
K970501 · LPH
Biomet, Inc.
Orthopedic · 79d
Cleared Apr 30, 1997
DEPUY ACE TROCHANTERIC SIDE PLATE
K970503 · HRS
Depuy Ace Medical Co.
Orthopedic · 79d
Cleared Apr 30, 1997
TITANIUM ALLOY BONE SCREWS
K970549 · HWC
Aesculap, Inc.
Orthopedic · 77d
Cleared Apr 30, 1997
BCW POWER ADVANTAGE WHEELCHAIR
K970743 · ITI
Wheelchairs of Kansas
Physical Medicine · 62d
Cleared Apr 30, 1997
IMTEC/TITANIUM MESH
K970841 · JEY
Imtec Corp.
Dental · 54d
Cleared Apr 30, 1997
TARGIS ALLOY #7
K970963 · EJT
Ivoclar North America, Inc.
Dental · 44d
Cleared Apr 29, 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · DXT
Medrad, Inc.
Cardiovascular · 161d
Cleared Apr 29, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT
K964695 · DCF
Beckman Instruments, Inc.
Immunology · 158d