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
143233–143256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1986
RICH-MAR RM 2002 ULTRASOUND PHYSICAL THERAPY DEVIC
K862469 · IMJ
Rich-Mar Corp.
Physical Medicine · 10d
Cleared Jul 10, 1986
HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)
K862555 · KIR
Viromed Laboratories, Inc.
Pathology · 7d
Cleared Jul 09, 1986
HUNTLEIGH DOPCORD, D140
K854267 · KNG
Huntleigh Technology, Inc.
Obstetrics & Gynecology · 259d
Cleared Jul 09, 1986
AIR-CUSHION TOCOTONOMETER
K860933 · HFM
International Biomedics, Inc.
Obstetrics & Gynecology · 119d
Cleared Jul 09, 1986
INTERSTIM 100 SYSTEM
K861136 · IPF
Buckman Co., Inc.
Physical Medicine · 105d
Cleared Jul 09, 1986
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
K861710 · DXK
Johnson & Johnson Professionals, Inc.
Cardiovascular · 65d
Cleared Jul 09, 1986
RESTOR (COMET)*DENTAL RESTORATIVE
K861833 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 57d
Cleared Jul 09, 1986
FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01
K862072 · HGL
International Biomedics, Inc.
Obstetrics & Gynecology · 40d
Cleared Jul 09, 1986
JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS
K862163 · FRO
Johnson & Johnson Professionals, Inc.
General & Plastic Surgery · 33d
Cleared Jul 09, 1986
# 10099/10225/10235/10275/10525/10625/10715/10125
K862193 · CAN
U.O. Equipment Co.
Anesthesiology · 30d
Cleared Jul 09, 1986
ARISE, VIVRE DEBOUT
K862305 · IPL
Natco Corp.
Physical Medicine · 22d
Cleared Jul 09, 1986
TANNING SOFA
K862341 · FTC
Hardwood Design Shop
General & Plastic Surgery · 19d
Cleared Jul 09, 1986
TAMPAX TAMPONS, VARIOUS SIZES/TYPES (MODIFICATION)
K862353 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 19d
Cleared Jul 09, 1986
ULTRATAN TANNING SYSTEM
K862372 · FTC
Health Systems Intl., Inc.
General & Plastic Surgery · 15d
Cleared Jul 09, 1986
THE RELAXARE EXERCISE AND MASSAGE UNIT
K862411 · JFB
Relaxare Corp.
Physical Medicine · 14d
Cleared Jul 08, 1986
ORTHOBLEND POWERED BONE MILL
K860356 · LYS
Zimmer, Inc.
Orthopedic · 159d
Cleared Jul 08, 1986
ADCOMP
K860610 · LHI
Healthtek, Inc.
General Hospital · 139d
Cleared Jul 08, 1986
CW DOPPLER STATIC TRANSDUCERS
K861109 · ITX
Advanced Technology Laboratories, Inc.
Radiology · 105d
Cleared Jul 08, 1986
GHI WET PENCIL
K861614 · GEI
Surgical Products Corp.
General & Plastic Surgery · 70d
Cleared Jul 08, 1986
MEDSURG CUSTOM DRESSING TRAYS
K861693
Medsurg Industries, Inc.
General & Plastic Surgery · 67d
Cleared Jul 08, 1986
HOWMEDICA HOFFMANN FIXATION PIN SYSTEM
K861766 · JDW
Howmedica Corp.
Orthopedic · 62d
Cleared Jul 08, 1986
STANDING WHEELER
K862013 · IPL
Engineering Mechanics, Co.
Physical Medicine · 41d
Cleared Jul 08, 1986
ARMBOARDS, REUSABLE AND DISPOSABLE
K862111
Abco Dealers, Inc.
General & Plastic Surgery · 35d
Cleared Jul 08, 1986
KING DIAGNOSTICS URIC ACID TEST
K862208 · KNK
King Diagnostics, Inc.
Chemistry · 28d