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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
100825–100848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 22, 1995
ILIAC CREST BONE MARROW ASPIRATION NEEDLE
K953082 · GDM
Baxter Healthcare Corp
General & Plastic Surgery · 81d
Cleared Sep 22, 1995
WOODBINE/SOLOS, HIGH RESOLUTION 3-CHIP SURGICAL CAMERA
K953086 · GCJ
Woodbine Optical Corp.
General & Plastic Surgery · 81d
Cleared Sep 22, 1995
MEDI-PLUS, HEALTH PLUS, SANITEX, RELIANCE
K953138 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 78d
Cleared Sep 22, 1995
QUICK READ 2000 (QR2000)
K953163 · LMD
Quicksilver Systems, Inc.
Radiology · 77d
Cleared Sep 22, 1995
MULTI-PRIME AKA/MONO-PRIME
K953476 · KLE
Silicon-Und Composite Spezialitaten GmbH
Dental · 60d
Cleared Sep 22, 1995
OLYMPIC PASTEURMATIC SYSTEM
K953645 · LDS
Olympic Medical Corp.
General Hospital · 49d
Cleared Sep 22, 1995
ORS-111
K953654 · KKX
O.R. Solutions, Inc.
General Hospital · 51d
Cleared Sep 22, 1995
PERSPECTIVES IMPREGNATED HYDROGEL WOUND DRESSING
K953669 · MGQ
Marketing Perspectives
General & Plastic Surgery · 46d
Cleared Sep 22, 1995
TECNOL ISLAND WOUND DRESSING
K954033 · MGP
Tecnol Medical Products, Inc.
General & Plastic Surgery · 25d
Cleared Sep 22, 1995
TELESCOPING PENEVAC
K954088 · GEI
I.C Medical, Inc.
General & Plastic Surgery · 22d
Cleared Sep 22, 1995
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
K954231 · FCG
Promex, Inc.
Gastroenterology & Urology · 11d
Cleared Sep 21, 1995
PHOENIX 4.0 MM DENTAL IMPLANT
K926309 · DZE
Vancouver Implant Center
Dental · 1010d
Cleared Sep 21, 1995
PHOENIX 4.0 MM ANGLED DENTAL ATTACHMENTS
K926311 · DZE
Vancouver Implant Center
Dental · 1010d
Cleared Sep 21, 1995
PHOENIX 3.25 MM C.P. COATED DENTAL IMPLANT
K926366 · DZE
International Implant Seminars
Dental · 1003d
Cleared Sep 21, 1995
PHOENIX 3.25 MM HA COATED DENTAL IMPLANT
K926367 · DZE
International Implant Seminars
Dental · 1003d
Cleared Sep 21, 1995
STRAIGHT 3.25 MM DENTAL IMPLANT ATTACHMENTS
K926370 · DZE
International Implant Seminars
Dental · 1003d
Cleared Sep 21, 1995
INTEGRAL IV BIOINTEGRATED DENTAL IMPLANT SYSTEM
K943180 · DZE
Calcitek, Inc.
Dental · 447d
Cleared Sep 21, 1995
WELLS JOHNSON FIXATION SYSTEM
K945500 · JEY
Wells Johnson Co.
Orthopedic · 316d
Cleared Sep 21, 1995
PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)
K950331 · BZD
Healthdyne, Inc.
Anesthesiology · 237d
Cleared Sep 21, 1995
ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE
K950803 · JJT
Isolab, Inc.
Chemistry · 212d
Cleared Sep 21, 1995
STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
K952058 · FOZ
Trinity Laboratories, Inc.
General Hospital · 142d
Cleared Sep 21, 1995
INTRAVASCULAR (I-V) ADMININISTRATION SET (DVGENPERS FPA)
K952160 · FPA
Medex, Inc.
General Hospital · 136d
Cleared Sep 21, 1995
JT-3 ELECTROGNATHOGRAPH
K952218 · NFS
Bio-Research Associates, Inc.
Dental · 133d
Cleared Sep 21, 1995
STA-COAG CONTROL [P] PLUS KIT
K952338 · GGC
American Bioproducts Co.
Hematology · 125d