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
173545–173568 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1977
PARALLEL BARS
K770611 · IOE
Will Ross Co.
Physical Medicine · 8d
Cleared Apr 08, 1977
SPLINT, BOHLER
K770612 · IQI
Will Ross Co.
Physical Medicine · 8d
Cleared Apr 08, 1977
AUDIOMETER, MA29, PURE TONE AIR CONDUCT.
K770616 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 7d
Cleared Apr 08, 1977
AUDIOMETER, MA31
K770618 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 7d
Cleared Apr 08, 1977
CONDUCTIVE CREAM-500
K770623 · GYB
Graphic Controls Corp.
Neurology · 4d
Cleared Apr 08, 1977
GAS COLLHCTOR BE 155(155-2-3,154-4)
K770632 · KGK
Instrumentation Industries, Inc.
Anesthesiology · 4d
Cleared Apr 08, 1977
ADAPTER BE 105-101 & 125-101
K770634 · BZA
Instrumentation Industries, Inc.
Anesthesiology · 4d
Cleared Apr 07, 1977
ULTRA LOW LEVEL IMMUNOGLOBULIN G
K761224 · DEW
Intl. Diagnostic Technology
Immunology · 120d
Cleared Apr 07, 1977
LOW LEVEL HUMAN ALBUMIN TEST KITS
K761225 · DCF
Intl. Diagnostic Technology
Immunology · 120d
Cleared Apr 07, 1977
HUMIDIFIER, DISPOSABLE
K770415 · BTT
M.G. Humidifiers, Inc.
Anesthesiology · 34d
Cleared Apr 07, 1977
PULSE GENERATOR, LITKICRON MODEL 3-70H
K770507 · DXY
Medcor, Inc.
Cardiovascular · 21d
Cleared Apr 07, 1977
STERILIZER WRAP
K770514 · FRG
C.R. Bard, Inc.
General Hospital · 21d
Cleared Apr 07, 1977
MONITOR, GAS MANIFOLD
K770614 · BXH
Dynatech Cryomedical Co.
Anesthesiology · 7d
Cleared Apr 07, 1977
1304A X-Y DISPLAY INTRODUCTION
K770615
Hewlett-Packard Co.
Radiology · 6d
Cleared Apr 07, 1977
AUDIOMETER, MA30, AIR & BONE CONDUCTION
K770617 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 6d
Cleared Apr 07, 1977
EXERCISOR, RESPIRATORY
K770619 · BWF
Cutter Laboratories, Inc.
Anesthesiology · 6d
Cleared Apr 07, 1977
CONDUCTIVITY GEL W/POTASSIUM CHLORIDE
K770622 · GYB
Graphic Controls Corp.
Neurology · 3d
Cleared Apr 06, 1977
LYMPHOCYTE TYPING, NEGATIVE CONTROL
K761008 · LGO
Hyland Therapeutic Div., Travenol...
Hematology · 155d
Cleared Apr 06, 1977
LYMPHOCYTE TYPING, POSITIVE CONTROL
K761009 · LGO
Hyland Therapeutic Div., Travenol...
Hematology · 155d
Cleared Apr 06, 1977
MINICON
K770398 · JJH
Amicon, Inc.
Immunology · 35d
Cleared Apr 06, 1977
EXERCISER, EXTENSOR WAND
K770436 · ION
Maddak, Inc.
Physical Medicine · 30d
Cleared Apr 06, 1977
IN VITRO T-3 UPTAKE TEST
K770480 · KHQ
Clinical Assays, Inc.
Immunology · 26d
Cleared Apr 06, 1977
RIA-DAC TM HTSH KIH
K770604 · JLW
Mallinckrodt Critical Care
Immunology · 6d
Cleared Apr 06, 1977
STOCKINETTE, SURGICAL
K770621 · KKX
The Torrent Corp.
General Hospital · 5d