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
102193–102216 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 1995
ULTRACISION HARMONIC SCAPEL
K952726 · GEI
Ultracision, Inc.
General & Plastic Surgery · 9d
Cleared Jun 22, 1995
OVAMED FALLOPIAN OSTIAL ACCESS CATHETER
K931167 · LKF
Ovamed Corp.
Obstetrics & Gynecology · 836d
Cleared Jun 22, 1995
THE HILL ADJUSTABLE RATH MECHANICAL TABLE
K942109 · INQ
Hill Laboratories Co.
Physical Medicine · 416d
Cleared Jun 22, 1995
THE HILL ADJUSTABLE EXTEND-R TABLE
K942256 · INQ
Hill Laboratories Co.
Physical Medicine · 409d
Cleared Jun 22, 1995
FILTRYZER
K942681 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 380d
Cleared Jun 22, 1995
TROJAN POLYURETHANE CONDOM
K942697 · MOL
Carter Products
Obstetrics & Gynecology · 379d
Cleared Jun 22, 1995
SAXON GOLD ULTRA SPERMICIDAL RAINBOW CONDOM
K943933 · HIS
Aladan Corp.
Obstetrics & Gynecology · 314d
Cleared Jun 22, 1995
ISOLA SPINE SYSTEM
K944737 · MNH
Acromed Corp.
Orthopedic · 269d
Cleared Jun 22, 1995
LMD GIARDIA ANTIGEN DETECTION ASSAY
K944871 · MHI
Lmd Laboratories
Microbiology · 262d
Cleared Jun 22, 1995
DYNATRON 250
K944935 · IPF
Dynatronics Corp.
Physical Medicine · 259d
Cleared Jun 22, 1995
ROUNDED CANNULATED INSIDE-OUT (RCI) ACL SCREW
K945687 · HWC
Smith and Nephew Donjoy, Inc.
Orthopedic · 213d
Cleared Jun 22, 1995
BACKCYCLER CPM(TM)
K945690 · BXB
Ergomedics, Inc.
Physical Medicine · 213d
Cleared Jun 22, 1995
WEBB-MORLEY SPINE SYSTEM
K945781 · KWP
Electro-Biology, Inc.
Orthopedic · 209d
Cleared Jun 22, 1995
SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE
K950216 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 154d
Cleared Jun 22, 1995
SURVIVAL KIT
K950357 · LYY
Opportunity Resources, Inc.
General Hospital · 147d
Cleared Jun 22, 1995
OSTEOTECH NAVICULAR AND CANCELLOUS CANNULATED SCREWS
K950652 · HWC
Osteotech, Inc.
Orthopedic · 129d
Cleared Jun 22, 1995
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM - PEDICLE FIXATION
K950697 · MNH
Depuy Motech
Orthopedic · 136d
Cleared Jun 22, 1995
MEDI-TRAC EEG ELECTRODE
K950782 · GXY
Graphic Controls Corp.
Neurology · 121d
Cleared Jun 22, 1995
LESINSKI SURGICAL EAR DRESSING
K950906 · EFQ
Microtek Medical, Inc.
General & Plastic Surgery · 114d
Cleared Jun 22, 1995
BRAUN PTA BALLOON CATHETER
K951248 · LIT
B.Braun Medical, Inc.
Cardiovascular · 94d
Cleared Jun 22, 1995
VS11 SF
K951271 · EJT
Metalor Dental USA Corp.
Dental · 93d
Cleared Jun 22, 1995
BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES
K951307 · DQX
Baxter Healthcare Corp
Cardiovascular · 92d
Cleared Jun 22, 1995
LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW
K951415 · HRS
Howmedica Corp.
Orthopedic · 86d
Cleared Jun 22, 1995
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM
K951508 · DTK
Boston Scientific Corp
Cardiovascular · 80d