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
132313–132336 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1989
CEPHALOTOMY SCISSORS
K890388 · KNB
Kinetic Medical Products
Obstetrics & Gynecology · 21d
Cleared Feb 13, 1989
UMBILICAL SCISSORS
K890389 · HDJ
Kinetic Medical Products
Obstetrics & Gynecology · 21d
Cleared Feb 13, 1989
ZENITH 40% PHOSPHORIC ACID GEL
K890464 · EBC
Foremost Dental Mfg., Inc.
Dental · 14d
Cleared Feb 13, 1989
AQUACISER SYSTEM
K890548 · ILJ
Aquaciser, Inc.
Physical Medicine · 10d
Cleared Feb 13, 1989
CP&S DISPOSABLE INSTANT COLD COMPRESS
K890553 · IMD
Consolidated Products & Services, Inc.
Physical Medicine · 7d
Cleared Feb 13, 1989
CP&S DISPOSABLE INSTANT SUPER HOT COMPRESS
K890554 · IMD
Consolidated Products & Services, Inc.
Physical Medicine · 7d
Cleared Feb 13, 1989
PATIENT MOVER(TM)
K890555 · ILK
T.B.S., Inc.
Physical Medicine · 7d
Cleared Feb 10, 1989
SURGI-CUF STERILE/NON-STERILE DISPOSABLE
K883977 · DXQ
Ethox Corp.
Cardiovascular · 143d
Cleared Feb 10, 1989
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
K884547 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 102d
Cleared Feb 10, 1989
AFP MODEL 262T PULSE GENERATOR
K884733 · DXY
Pacesetter Systems
Cardiovascular · 92d
Cleared Feb 10, 1989
IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY
K884771 · JFP
Instrumentation Laboratory CO
Chemistry · 88d
Cleared Feb 10, 1989
AME PINSITE SHIELD(TM)
K884798 · JEC
American Medical Electronics, Inc.
Orthopedic · 86d
Cleared Feb 10, 1989
DENTAL CHAIR F1
K884830 · KLC
Fimet OY
Dental · 84d
Cleared Feb 10, 1989
STERI-OSS
K884845 · DZE
Denar Corp.
Dental · 81d
Cleared Feb 10, 1989
PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO
K884864 · JJQ
The Perkin-Elmer Corp.
Toxicology · 80d
Cleared Feb 10, 1989
DADC '500' DRIVING CONTROL
K884899 · IPQ
Driving Aids Development Corp.
Physical Medicine · 74d
Cleared Feb 10, 1989
BIOTROL ALBUMIN
K885094 · CIX
Biotrol, USA, Inc.
Chemistry · 63d
Cleared Feb 10, 1989
CLINISTAT TRIGLYCERIDES REAGENT TEST
K885134 · JGY
Heraeus Kulzer, Inc.
Chemistry · 60d
Cleared Feb 10, 1989
ABSORBENT GAUZE ROLL
K885143 · EFQ
Smith & Nephew, Inc.
General & Plastic Surgery · 57d
Cleared Feb 10, 1989
VENTREX COATED TUBE HIGH SENSITIVITY TSH
K885157 · JLW
Ventrex Laboratories, Inc.
Chemistry · 59d
Cleared Feb 10, 1989
MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD
K885240 · DTB
Tpl-Cordis, Inc.
Cardiovascular · 51d
Cleared Feb 10, 1989
HDL CHOLESTEROL TEST
K885265 · LBR
Em Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Feb 10, 1989
DENTAL SYRINGE APPLICATION TIP
K890064 · EKJ
Centrix, Inc.
Dental · 32d
Cleared Feb 10, 1989
IMX FOLLICLE STIMULATING HORMONE (FSH)
K890135 · CGJ
Abbott Laboratories
Chemistry · 28d