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
119857–119880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 13, 1991
OHMEDA - OHIO CAR PLUS INCUBATOR, MODIFICATION
K913154 · FMZ
Ohmeda Medical
General Hospital · 63d
Cleared Sep 13, 1991
TDM I LINEARITY TEST SET
K913309 · DIF
Casco Standards
Chemistry · 50d
Cleared Sep 13, 1991
SAFETY INJECTION PORT, MODIFICATION
K913311 · FPA
Riverside Technology, Inc.
General Hospital · 56d
Cleared Sep 13, 1991
ICAN NEEDLE COUNTERS
K913446 · MMK
Icn Pharmaceuticals, Inc.
General Hospital · 42d
Cleared Sep 13, 1991
URINARY/CSF PROTEIN
K913615 · JGQ
Boehringer Mannheim Corp.
Chemistry · 31d
Cleared Sep 12, 1991
CORDLESS ELECTRIC MASSAGER EV315
K912634 · ISA
Matsushita Electric Co.
Physical Medicine · 90d
Cleared Sep 11, 1991
CARDIOTRACE-I TRANSTELEPHONIC ECG RECEIV CONSOLE
K911308 · DXH
Medical Equipment Designs, Inc.
Cardiovascular · 173d
Cleared Sep 11, 1991
DANEK SACRAL HOOK, MODIFICATION
K911379 · KWP
Danek Medical, Inc.
Orthopedic · 168d
Cleared Sep 11, 1991
CVIS INSIGHT IMAGING CATHETERS
K911414 · ITX
Cardiovascular Imaging Systems, Inc.
Radiology · 163d
Cleared Sep 11, 1991
VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE
K912141 · FPA
Baxter Healthcare Corp
General Hospital · 120d
Cleared Sep 11, 1991
IMX SELECT ANALYZER
K912368 · JJQ
Abbott Laboratories
Chemistry · 105d
Cleared Sep 11, 1991
NOVA 13 ANALYZER
K912561 · CGZ
Nova Biomedical Corp.
Chemistry · 92d
Cleared Sep 11, 1991
20CM/H20 PEEP VALVE
K912578 · BYE
Vital Signs, Inc.
Anesthesiology · 91d
Cleared Sep 11, 1991
QUIK-PACE(R) OR EX-PACE(TM) PEDIATRIC PACING ELEC
K912599 · DRO
Physio-Control Corp.
Cardiovascular · 93d
Cleared Sep 11, 1991
FLOCARE LF-A
K912699 · BYD
Flocare Medical
Anesthesiology · 84d
Cleared Sep 11, 1991
FLOCARE DRY CAS SAMPLING PORT MODELS
K912700 · BYD
Flocare Medical
Anesthesiology · 84d
Cleared Sep 11, 1991
MX 339 TWIN HEMOSTATIC Y CONNECTOR
K912709 · DTL
Medex, Inc.
Cardiovascular · 84d
Cleared Sep 11, 1991
HYPER-K HEAT SYSTEM
K912722 · ILO
Baxter Healthcare Corp
Physical Medicine · 85d
Cleared Sep 11, 1991
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
K912806 · KHS
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Sep 11, 1991
OPEN ENDED GUIDEWIRE
K912878 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 72d
Cleared Sep 11, 1991
MORSE VASCULAR INTRODUCER SET
K912961 · DYB
North American Instrument Corp.
Cardiovascular · 65d
Cleared Sep 11, 1991
SLIP-PRUF-CLINGER
K913049 · KDD
Macbrud Corp. Medical Div.
General & Plastic Surgery · 64d
Cleared Sep 11, 1991
TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE
K913207 · KGO
Baxter Healthcare Corp
General Hospital · 54d
Cleared Sep 11, 1991
OPUS(R) PLUS ANALYZER
K913295 · JJQ
Pb Diagnostic Systems, Inc.
Chemistry · 49d