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
120313–120336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1991
DOBBHOFF(R) BIPOLAR HEMOSTATIC PROBE
K912129 · KNS
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 85d
Cleared Aug 07, 1991
OPERAND LUBRICATING JELLY
K912132 · FHX
General Medical Co.
Gastroenterology & Urology · 85d
Cleared Aug 07, 1991
MONARK ERGOMETERS
K912227 · ISD
Quinton, Inc.
Physical Medicine · 83d
Cleared Aug 07, 1991
LANDERS 3 STRUT IRRIGATING VITRECTOMY LENS RING
K912253 · HQE
Ocular Instruments, Inc.
Ophthalmic · 78d
Cleared Aug 07, 1991
LANDERS NOTCHED VITRECTOMY LENS RING
K912268 · HNH
Ocular Instruments, Inc.
Ophthalmic · 77d
Cleared Aug 07, 1991
LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING
K912269 · HNH
Ocular Instruments, Inc.
Ophthalmic · 77d
Cleared Aug 07, 1991
TUBE HOUSING ASSEMBLIES
K912338 · ITY
Comet Ltd. C/O Radiology Resources, Inc.
Radiology · 75d
Cleared Aug 07, 1991
PHILIPS DIAGNOST 96
K912470 · JAA
Philips Medical Systems, Inc.
Radiology · 64d
Cleared Aug 07, 1991
GROUP A STREP POSITIVE AND NEGATIVE CONTROLS
K912868 · GTZ
Quidel Corp.
Microbiology · 40d
Cleared Aug 07, 1991
LATEX EXAMINATION GLOVES
K913033 · LYY
Reagent Hospital Prod. , Ltd.
General Hospital · 29d
Cleared Aug 05, 1991
GUARANTY HAIR REMOVAL SYSTEM
K905125 · KCX
Stephens Mfg. Co.
General & Plastic Surgery · 264d
Cleared Aug 02, 1991
SMART-EP
K904926 · GWJ
Intelligent Hearing Systems
Neurology · 275d
Cleared Aug 02, 1991
CATHLAB SILICONE BILIARY BALLOON CATHETER
K910917 · GCA
Cathlab Corp.
Gastroenterology & Urology · 150d
Cleared Aug 02, 1991
TECNADYNE SURGI-SQUEEZE INFUSION PUMP
K910926 · KZD
Tecnadyne Scientific, Inc.
General Hospital · 150d
Cleared Aug 02, 1991
HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED
K910950 · BZG
Vitalog Monitoring,Inc.
Anesthesiology · 157d
Cleared Aug 02, 1991
OHMEDA MODEL 4700 OXICAP
K911193 · CCK
Ohmeda Medical
Anesthesiology · 137d
Cleared Aug 02, 1991
CALIBRATION KIT
K911264 · BXK
S & W Medico Teknik
Anesthesiology · 144d
Cleared Aug 02, 1991
ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE
K911520 · KKX
Andronic Devices, Ltd.
General Hospital · 120d
Cleared Aug 02, 1991
ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP
K911521 · KKX
Andronic Devices, Ltd.
General Hospital · 120d
Cleared Aug 02, 1991
DUAL COMPARTMENT TPN BAG 3 LITER
K911567 · KPE
Stedim, Inc.
General Hospital · 115d
Cleared Aug 02, 1991
STAYFREE, UNSCENTED/SCENTED/SCENTED DEODOR MEN PAD
K911637 · HAD
Personal Products Co.
Neurology · 113d
Cleared Aug 02, 1991
3RD HAND HELPER
K911815 · FPA
Aaron Medical Industries
General Hospital · 100d
Cleared Aug 02, 1991
DYNAVISION 2000
K911938 · LQD
Performance Ent.
Neurology · 93d
Cleared Aug 02, 1991
MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM
K911964 · FRN
Abbott Laboratories
General Hospital · 92d