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
151705–151728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 1984
WOODLYN CLASSIC KERATOMETER
K841767 · HLI
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
AMERICAN MEDICAL OPTICS PHOTOKERATO
K842128 · HJA
American Medical Optics
Ophthalmic · 70d
Cleared Aug 07, 1984
SERUM IRON & SERUM IRON BINDING CAPACI
K842155 · CFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Aug 07, 1984
SERUM IRON & SERUM IRON BINDING CAPACITY
K842156 · CFM
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 69d
Cleared Aug 07, 1984
IVAC 280 VOLUMETRIC INFUSION CONTROLLER
K842419 · LDR
Y
General Hospital · 48d
Cleared Aug 07, 1984
TDX REA IRON DIAGNOSTIC KIT
K842505 · CFM
Abbott Laboratories
Chemistry · 42d
Cleared Aug 07, 1984
DHEA-S DIRECT RIA KIT
K842555 · JKC
Biotecx Laboratories, Inc.
Chemistry · 36d
Cleared Aug 07, 1984
LUDLUM 88 DOSE CALIBRATOR
K842570 · KPT
Ludlum Measurements, Inc.
Radiology · 35d
Cleared Aug 07, 1984
COMMODE CHAIR 98200
K842651 · ILS
Guardian Products Co., Inc.
Physical Medicine · 28d
Cleared Aug 07, 1984
ROOTMAN ORBITAL SURGERY INSTRUMENT SET
K842697 · HNR
Downs Surgical , Ltd.
Ophthalmic · 27d
Cleared Aug 07, 1984
ORNITHINE INDOLE MOTILITY
K842851 · JSH
Anarobe Systems
Microbiology · 18d
Cleared Aug 07, 1984
DECARBOXYLASE TEST REAGENT
K842869 · JSF
Irvine Diagnostic Services
Microbiology · 15d
Cleared Aug 07, 1984
HIPPURATE TEST REAGENT
K842871 · JSF
Irvine Diagnostic Services
Microbiology · 15d
Cleared Aug 07, 1984
T- EXTENSION SET T-04-C
K842985 · FPA
Tico Medical Instruments, Inc.
General Hospital · 8d
Cleared Aug 07, 1984
VMT GENTLE-HALER
K842988 · CCQ
Vortran Medical Technology 1, Inc.
Anesthesiology · 8d
Cleared Aug 06, 1984
NEOS LP
K841633 · DXY
Biotronik Sales, Inc.
Cardiovascular · 109d
Cleared Aug 06, 1984
DESERET DISPOSABLE PRESSURE TRANSDUCER
K841968 · DRS
Parke-Davis Co.
Cardiovascular · 83d
Cleared Aug 06, 1984
INFUSAID INFUSE-A-PORT
K842355 · LJT
Infusaid Corp.
General Hospital · 46d
Cleared Aug 03, 1984
PALL EC PLUS FILTER
K834380 · DTM
Pall Biomedical Products Co.
Cardiovascular · 233d
Cleared Aug 03, 1984
PALL EC PLUS FILTER W/FILTER SLEEVE
K834382 · DTM
Pall Biomedical Products Co.
Cardiovascular · 233d
Cleared Aug 03, 1984
ARTERIAL EMBOLECTOMY CATHETER
K840198 · DXE
Shiley, Inc.
Cardiovascular · 198d
Cleared Aug 03, 1984
ELECTROCARDIOGRAPH E-340
K840440 · DPS
Burdick Corp.
Cardiovascular · 184d
Cleared Aug 03, 1984
LITHIUM PACEMAKER 811-811L & 811XL
K840748 · DXY
Omikron Scientific, Ltd.
Cardiovascular · 162d
Cleared Aug 03, 1984
POROUS HYDROXYAPATITE BG200
K841201 · LYC
Interpore Intl.
Dental · 135d