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
144073–144096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1986
R1361 & R1372 MEASURED EXERCISE EQUIPMENT
K861348 · ISD
Tri W-G, Inc.
Physical Medicine · 25d
Cleared May 02, 1986
R1436,R1697,R1699,R1564,R1216,R1214,R854 & R1213
K861350 · INW
Tri W-G, Inc.
Physical Medicine · 25d
Cleared May 02, 1986
R1698,R1701,R1215,R1700 & R860 POWERED TABLES
K861352 · INQ
Tri W-G, Inc.
Physical Medicine · 25d
Cleared May 02, 1986
PAP SMEAR KIT
K861389 · HHT
Intl. Cytobrush, Inc.
Obstetrics & Gynecology · 18d
Cleared May 02, 1986
HANDHELD DYNAMOMETER, MODEL #160 AND #111
K861396 · HRW
Spark Instruments & Academics, Inc.
Neurology · 17d
Cleared May 02, 1986
SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101
K861460 · LJK
Widran Urological Group, Ltd.
Microbiology · 14d
Cleared May 02, 1986
#CTO 100 (CERVICAL TRACTION ORTHOSIS 100)
K861470 · HAX
Applied Medical Systems
Neurology · 10d
Cleared May 02, 1986
PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT
K861474 · CBQ
Datex Division Instrumentarium Corp.
Anesthesiology · 10d
Cleared May 02, 1986
HEARING AID (ALL IN THE EAR)
K861492 · ESD
Crystal Tone Hearing Instruments
Ear, Nose, Throat · 10d
Cleared May 02, 1986
DISPOSABLE BERMAN AND GUEDEL AIRWAYS
K861540 · CAE
Dryden Corp.
Anesthesiology · 8d
Cleared May 02, 1986
SERVO GAS MONITOR 120
K861625 · CCL
Siemens Elema AB
Anesthesiology · 3d
Cleared May 01, 1986
FORAN CORP-SURESERT INTRAVENOUS CATHETER PLACE UNI
K853988 · FOZ
Foran Industries, Inc.
General Hospital · 216d
Cleared May 01, 1986
DCI MODEL EP-2 CLINICAL STIMULATOR
K854196 · DRO
Digital Cardiovascular Instruments, Inc.
Cardiovascular · 198d
Cleared May 01, 1986
CORDOT R
K854618 · LFX
Cordis Corp.
Microbiology · 164d
Cleared May 01, 1986
INFAGUARD TM
K854705 · BZQ
Lifewatch Systems, Inc.
Anesthesiology · 161d
Cleared May 01, 1986
GREEN-LINE BIPOLAR COAGULATION UNIT
K860479 · GEI
Grieshaber & Co.
General & Plastic Surgery · 83d
Cleared May 01, 1986
VMA BY HPLC TEST (VANILMANDELIC ACID)
K861010 · CDF
Bio-Rad
Chemistry · 44d
Cleared May 01, 1986
SPECTRO VWF
K861159 · GGP
Ramco Laboratories, Inc.
Hematology · 34d
Cleared May 01, 1986
MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG
K861434 · LHI
Churchill Corp.
General Hospital · 14d
Cleared Apr 30, 1986
KOI PACHYMETER
K843247 · ITX
Koi, Inc.
Radiology · 618d
Cleared Apr 30, 1986
PAINBLOCKER WA5000
K854334 · GXH
Wallach Surgical Devices, Inc.
Neurology · 184d
Cleared Apr 30, 1986
ELECTROCARDIOGRAPH CONTINUOUS MONITOR
K860457 · GWN
Oxford Medilog, Inc.
Neurology · 84d
Cleared Apr 30, 1986
DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST
K860470 · DSI
Del Mar Avionics
Cardiovascular · 83d
Cleared Apr 30, 1986
DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER
K860471 · DSI
Del Mar Avionics
Cardiovascular · 83d