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
150409–150432 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 27, 1984
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K842979 · HQC
CooperVision, Inc.
Ophthalmic · 120d
Cleared Nov 27, 1984
IOCARE IRRIGATION/ASPIRATION PACK
K843275 · HQC
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Nov 27, 1984
IOCARE PHACOEMULSIFICATION PACK
K843277 · HQC
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Nov 27, 1984
IOCARE ULTRASONIC TITANIUM TIPS
K843278 · HQC
Chiron Vision Corp.
Ophthalmic · 99d
Cleared Nov 27, 1984
FLOOR MOUNTED X-RAY TUBESTAND
K843335 · IYB
Medicor USA , Ltd.
Radiology · 92d
Cleared Nov 27, 1984
PORTA-STAT
K843340 · IWY
Porta-Stat, Inc.
Radiology · 92d
Cleared Nov 27, 1984
MENDEZ U/S CYSTOTOME
K843386 · HQC
CooperVision, Inc.
Ophthalmic · 91d
Cleared Nov 27, 1984
STRESS CONTROL BIOFEEDBACK CARD
K843413 · HCC
Pilgrim Plastic Products Co.
Neurology · 88d
Cleared Nov 27, 1984
MEI MAMMOGRAPHY SYS MX-2049
K843437 · IZH
Moti Enterprises, Inc.
Radiology · 84d
Cleared Nov 27, 1984
ULTRA LYTE SODIUM REAGENT KIT
K843453 · JGS
Ultra Quest Diagnostics, Inc.
Chemistry · 83d
Cleared Nov 27, 1984
ULTRA LYTE POTASSIUM REAGENT KIT
K843454 · CEM
Ultra Quest Diagnostics, Inc.
Chemistry · 83d
Cleared Nov 27, 1984
PETIT BANDS
K843587 · KGX
Micori Gifts, Inc.
General & Plastic Surgery · 102d
Cleared Nov 27, 1984
TRIGLYCERIDES REAGENT SYSTEM
K843832 · CDT
Fermco Biochemics, Inc.
Chemistry · 57d
Cleared Nov 27, 1984
UNIVERSAL-ERGOTEST
K843850 · ISD
Erich Jaeger, Inc.
Physical Medicine · 57d
Cleared Nov 27, 1984
LAUF-ERGOTEST
K843853 · IOL
Erich Jaeger, Inc.
Physical Medicine · 57d
Cleared Nov 27, 1984
ERGOTEST 40 & 45
K843855 · ISP
Erich Jaeger, Inc.
Physical Medicine · 57d
Cleared Nov 27, 1984
LAUF-ERGOTEST JUNIOR
K843859 · IOL
Erich Jaeger, Inc.
Physical Medicine · 57d
Cleared Nov 27, 1984
ULTIMA CHIROPRACTIC TABLES
K843877 · INQ
Elenex Medequip, Inc.
Physical Medicine · 56d
Cleared Nov 27, 1984
LOW PROFILE STEERABLE BALLOON DILATION
K843880 · LIT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 56d
Cleared Nov 27, 1984
POCKET OPHTHALMOSCOPE GH
K843897 · HLJ
Design Med. Corp.
Ophthalmic · 55d
Cleared Nov 27, 1984
COBAS FLUORESCENCE POLARIZATION MODULE
K843914 · JJG
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Nov 27, 1984
STAT-TRAK PLUS LIQUID CHEMISTRY CONTROLS 1,2 & 3
K843986 · JJY
United Diagnostics, Inc.
Chemistry · 47d
Cleared Nov 27, 1984
GAS TRAK BRAND CO-OXIMETER CONTROLS 1,2 & 3
K844018 · JJY
United Diagnostics, Inc.
Chemistry · 47d
Cleared Nov 27, 1984
SERACON TM SR IV
K844026 · JIX
Bhp Diagnostix, Inc.
Chemistry · 43d