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
90721–90744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 08, 1998
CHEMO-SPIKE II RECONSTITUTION DEVICE
K974431 · LHI
Medi-Dose, Inc.
General Hospital · 45d
Cleared Jan 08, 1998
MANAN AUTOMATIC CUTTING NEEDLE
K974446 · KNW
Manan Medical Products, Inc.
Gastroenterology & Urology · 44d
Cleared Jan 08, 1998
MANAN ACCURA NEEDLE
K974741 · GAA
Medical Device Technologies, Inc.
General & Plastic Surgery · 20d
Cleared Jan 08, 1998
MANAN TECHNA-CUT ASPIRATION NEEDLE
K974766 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 17d
Cleared Jan 08, 1998
TRIAGE(R) CARDIAC PANEL CALIBRATION VERIFICATION CONTROLS, TRIAG (R)...
K974827 · JJY
Biosite Incorporated
Chemistry · 15d
Cleared Jan 07, 1998
OVULON MONITOR
K973860 · NGE
Conception Technology, Inc.
Toxicology · 90d
Cleared Jan 07, 1998
TRACE REAGENT LINE FOR THE COBAS MIRA
K973869 · CKA
Trace America, Inc.
Chemistry · 105d
Cleared Jan 07, 1998
ELECTRODES/PROBES/DEVICES
K974637 · FAS
Ximed/Prosure/Injectx
Gastroenterology & Urology · 26d
Cleared Jan 06, 1998
SHENG HO
K964819 · LYY
Shang HO Industrial Corp. , Ltd.
General Hospital · 400d
Cleared Jan 06, 1998
SANKO INTRAORAL DENTAL X-RAY
K972921 · EHD
Sanko X-Ray Manufacturing Co., Ltd.
Radiology · 151d
Cleared Jan 06, 1998
PATIENT EXAMINATION POWDER-FREE GLOVES
K973020 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 146d
Cleared Jan 06, 1998
PRE-POWDERED PATIENT EXAMINATION GLOVE
K973831 · LYY
Safe Glove , Ltd.
General Hospital · 91d
Cleared Jan 06, 1998
PHILIPS EASYVISION WORKSTATION
K973835 · LLZ
Philips Medical Systems, Inc.
Radiology · 90d
Cleared Jan 06, 1998
CLS STEM, WAGNER REVISION STEM, ALLOCLASSIC ZWEYMULLER STEM, SL
K973837 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Jan 06, 1998
BIOABSORBABLE BANKART TACK
K973849 · MAI
Hogan & Hartson
Orthopedic · 90d
Cleared Jan 06, 1998
POWDER FREE HYPROALLERGENIC EXAMINATION GLOVE (WITH LOW PROTEIN CLAIM)
K974065 · LYY
Tillotson Healthcare Corp.
General Hospital · 71d
Cleared Jan 06, 1998
PHYSIO/1000
K974070 · FNM
Physio Designs, Inc.
General Hospital · 70d
Cleared Jan 06, 1998
V3 VALVE
K974145 · FPA
B.Braun Medical, Inc.
General Hospital · 64d
Cleared Jan 06, 1998
ELECSYS PSA (ON ELECSYS 1010)
K974189 · LTJ
Boehringer Mannheim Corp.
Immunology · 60d
Cleared Jan 06, 1998
MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED
K974296 · FNL
Invacare Corp.
General Hospital · 50d
Cleared Jan 06, 1998
APOLLO 9500
K974369 · EBZ
Ion Laser Technology
Dental · 47d
Cleared Jan 06, 1998
CHASE ANASTOMOSIS VISUALIZATION DEVICE
K974568 · FQH
Chase Medical, Inc.
General Hospital · 32d
Cleared Jan 06, 1998
RANDOX IRON
K974604 · JMO
Randox Laboratories, Ltd.
Chemistry · 27d
Cleared Jan 06, 1998
REP CHOLESTEROL PROFILE CONTROL-II
K974609 · JJX
Helena Laboratories
Chemistry · 27d