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
149593–149616 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 19, 1985
CLINIC ELECTRONIC THERMOMETER
K850564 · FLL
Gemini Electronics Co. , Ltd.
General Hospital · 7d
Cleared Feb 15, 1985
WHITE OCULAR PRESSURE RELIEF DEVICE
K840204 · KYF
Precision-Cosmet Co., Inc.
Ophthalmic · 393d
Cleared Feb 15, 1985
HOME PRO VOLUMETRIC INFUSION PUMP
K841374 · FRN
American Edwards Laboratories
General Hospital · 318d
Cleared Feb 15, 1985
NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE
K843596 · HLI
Nidek, Inc.
Ophthalmic · 156d
Cleared Feb 15, 1985
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
K843597 · HLI
Nidek, Inc.
Ophthalmic · 156d
Cleared Feb 15, 1985
CARE ELECTRIC BREAST PUMP
K844013 · HGX
Hankscraft Div. of Gerber Products Co.
Obstetrics & Gynecology · 126d
Cleared Feb 15, 1985
OVUDATE
K844043 · LHD
Joel R.L. Ehren Kranz
Obstetrics & Gynecology · 121d
Cleared Feb 15, 1985
NUTRIMIX EMPTY CONTAINER
K844077 · KPE
Abbott Laboratories
General Hospital · 119d
Cleared Feb 15, 1985
OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR
K844277 · DXG
Omikron Scientific, Ltd.
Cardiovascular · 102d
Cleared Feb 15, 1985
FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD
K844750 · FKQ
Seratronics, Inc.
Gastroenterology & Urology · 71d
Cleared Feb 15, 1985
SYVA SAMPLE SEAL
K844949 · KIE
Syva Co.
Toxicology · 57d
Cleared Feb 15, 1985
MONOCULAR DIRECT OPHTHALMOSCOPE
K844971 · HLI
Nidek, Inc.
Ophthalmic · 53d
Cleared Feb 15, 1985
POLLENEX DIGITAL THERMOMETER T-125
K850362 · FLL
Associated Mills, Inc.
General Hospital · 16d
Cleared Feb 15, 1985
POLLENEX DIGITAL THERMOMETER T-225
K850363 · FLL
Associated Mills, Inc.
General Hospital · 16d
Cleared Feb 15, 1985
QUINTON WHITE SEALING CAP
K850369 · FOZ
Quinton, Inc.
General Hospital · 15d
Cleared Feb 15, 1985
LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS-
K850432 · LLO
Cooper Lasersonics, Inc.
Anesthesiology · 11d
Cleared Feb 14, 1985
YKI-770 ELECTRONIC SPHYGMOMAMETER
K842318 · DXN
Yukosha Co., Inc.
Cardiovascular · 247d
Cleared Feb 14, 1985
CILCO I/A SURGICAL PACK
K843319 · HQC
Cilco, Inc.
Ophthalmic · 174d
Cleared Feb 14, 1985
KANGAROO NASOGASTRIC FEEDING TUBE
K843567 · KNT
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 157d
Cleared Feb 14, 1985
CARDIOTOMY RESERVOIR W/FILTER
K843595 · DTN
Omnis Surgical, Inc.
Cardiovascular · 155d
Cleared Feb 14, 1985
UNIVERSAL-BODYTEST
K843846 · CCM
Erich Jaeger, Inc.
Anesthesiology · 136d
Cleared Feb 14, 1985
BODYSCREEN II
K843851 · CCM
Erich Jaeger, Inc.
Anesthesiology · 136d
Cleared Feb 14, 1985
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
K843888 · DTN
Gish Biomedical, Inc.
Cardiovascular · 135d
Cleared Feb 14, 1985
PEDIATRIC SIZE K-TUBE A OR B
K843939 · KNT
Midwest Metabolic Support Group
Gastroenterology & Urology · 128d