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
157609–157632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 23, 1983
ESA ARTHROSCOPY CANNULA TRAY
K823832 · HRX
Concept, Inc.
Orthopedic · 64d
Cleared Feb 23, 1983
SDC RECTAL TEMP. PROBE PRODUCT #1020
K830039 · FLL
Science Development Corp.
General Hospital · 47d
Cleared Feb 23, 1983
POLYESTER X-RAY DETECTABLE STRUNG-SPONGE
K830201 · GDY
American Medical Disposable, Inc.
General & Plastic Surgery · 34d
Cleared Feb 23, 1983
COTTON BALLS, X-RAY OPAQUED STRUNG & NON
K830202 · GDY
American Medical Disposable, Inc.
General & Plastic Surgery · 34d
Cleared Feb 23, 1983
FRANZEN NEEDLE GUIDE
K830235 · GDM
Precision Dynamics Corp.
General & Plastic Surgery · 29d
Cleared Feb 19, 1983
SOLUTION TRANSFER CONTAINER
K830299 · KPE
The Healthcare Group Laboratories, Inc.
General Hospital · 22d
Cleared Feb 18, 1983
AFP SYSTEM PULSE GENERATOR MODEL 261/262
K822639 · DXY
Pacesetter Systems
Cardiovascular · 170d
Cleared Feb 18, 1983
SUTURE NEEDLES
K823229
Feuerstein Produktions
General & Plastic Surgery · 112d
Cleared Feb 18, 1983
AFP PULSE GENERATOR
K823559 · DXY
Pacesetter Systems
Cardiovascular · 78d
Cleared Feb 18, 1983
INTRA-AORTIC BALLOON SYSTEM
K823739 · DSP
Smec, Inc.
Cardiovascular · 67d
Cleared Feb 18, 1983
BLOOD GAS INCUBATOR #260650
K823766 · JRG
Boekel Industries, Inc.
Chemistry · 66d
Cleared Feb 18, 1983
COEURLOCK STERILE DISPOS. ANGIOGRAPHIC
K823920 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 52d
Cleared Feb 18, 1983
USCI TEMP. ATRIO-VENTRICULAR ELECTRODE
K830094 · LDF
C.R. Bard, Inc.
Cardiovascular · 38d
Cleared Feb 18, 1983
SELFAST
K830107 · EMA
North Pacific Dental, Inc.
Dental · 38d
Cleared Feb 18, 1983
HYDROL
K830112 · EJK
North Pacific Dental, Inc.
Dental · 38d
Cleared Feb 18, 1983
SULCARINGS
K830116 · EIF
North Pacific Dental, Inc.
Dental · 38d
Cleared Feb 18, 1983
EXTERNAL INFUSION PUMP
K830151 · FRN
Intermedics, Inc.
General Hospital · 32d
Cleared Feb 18, 1983
IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS
K830163 · DSI
Intl. Business Machines
Cardiovascular · 31d
Cleared Feb 18, 1983
DIGITAL BEDSIDE SCALE #5000
K830171 · FRW
Acme Medical Scale Co.
General Hospital · 31d
Cleared Feb 18, 1983
STERILE COTTON ROLLS #3, 1 1/2
K830175 · EFN
Veratex Corp.
Dental · 31d
Cleared Feb 18, 1983
BIOCELL SPINAL FLUID CONTROL
K830179 · JJY
Biocell Laboratories, Inc.
Immunology · 31d
Cleared Feb 18, 1983
NEURO DIAGNOSTICS MODEL FCR
K830191 · GWK
Neurodiagnostics, Inc.
Neurology · 29d
Cleared Feb 18, 1983
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID
K830195 · CDD
Diagnostic Products Corp.
Chemistry · 29d
Cleared Feb 18, 1983
DAC-CEL DIAGNATAL RD 50
K830203 · JHI
Wellcome Diagnostics
Chemistry · 29d