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
98017–98040 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1996
GASTROTEC
K954401 · ESI
Patrick C. Jacobssen
Ear, Nose, Throat · 218d
Cleared Apr 25, 1996
MERCURY AIRWAY PRESSURE MANOMETER
K954486 · CAP
Mercury Medical
Anesthesiology · 211d
Cleared Apr 25, 1996
APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)
K954800 · MEH
Intermedics Orthopedics
Orthopedic · 211d
Cleared Apr 25, 1996
POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)
K954976 · EBG
Healex Products, Inc.
Dental · 181d
Cleared Apr 25, 1996
NOVA CO-OXIMETER ANALYZER
K955013 · GLY
Nova Biomedical Corp.
Hematology · 176d
Cleared Apr 25, 1996
TACTYLON POWDER FREE EXAMINATION GLOVE
K955464 · LZA
Tactyl Technologies, Inc.
General Hospital · 147d
Cleared Apr 25, 1996
FLUID RESISTANT MASK
K955556 · FXX
American Threshold Healthcare
General Hospital · 142d
Cleared Apr 25, 1996
FLUID REISISTANT EYESHIELD MASK
K955557 · FXX
American Threshold Healthcare
General Hospital · 142d
Cleared Apr 25, 1996
OPUS CK-MB & TOTAL CK CONTROLS
K960275 · JJT
Behring Diagnostics, Inc.
Chemistry · 97d
Cleared Apr 25, 1996
ROTABLATOR SYSTEM'S GUIDE WIRE LINE: SUPPORT ROTAWIRE RAIL ROTA WIRE
K960379 · MCW
Heart Technology Mfg., Inc.
Cardiovascular · 90d
Cleared Apr 25, 1996
PRESSUREGUARD: LOW AIR LOSS MATTRESS SYSTEM
K960620 · FNM
Span-America Medical Systems, Inc.
General Hospital · 72d
Cleared Apr 25, 1996
VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT
K960706 · DSY
Carbomedics, Inc.
Cardiovascular · 64d
Cleared Apr 25, 1996
BIONIKE A/Q PREGNANCY TEST
K960992 · JHI
Bionike Laboratories, Inc.
Chemistry · 44d
Cleared Apr 25, 1996
ALT INCORPORATING DST
K961123 · CKA
Trace Scientific , Ltd.
Chemistry · 35d
Cleared Apr 25, 1996
ARGELITE 52+
K961211 · EJT
Argen Precious Metals, Inc.
Dental · 28d
Cleared Apr 25, 1996
ACCUSIGN MET/BIOSIGN MET
K961249 · LAF
Princeton BioMeditech Corp.
Toxicology · 24d
Cleared Apr 24, 1996
TOTAL PROTEIN (URINE)
K951222 · JIR
Randox Laboratories, Ltd.
Chemistry · 401d
Cleared Apr 24, 1996
VAPOR-TECH ROLLER BALL ELECTRODE 24 FR.
K954710 · FAS
Northgate Technologies, Inc.
Gastroenterology & Urology · 195d
Cleared Apr 24, 1996
AXSYM N-ACETYLPROCAINAMIDE
K955422 · LAN
Abbott Laboratories
Toxicology · 148d
Cleared Apr 24, 1996
AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3
K955690 · JJY
Clinical Controls, Inc.
Chemistry · 132d
Cleared Apr 24, 1996
SERUM VOLATILES CONTROL LEVEL 1 & 2
K955691 · JJY
Clinical Controls, Inc.
Chemistry · 132d
Cleared Apr 24, 1996
SPINAL SPECIALTIES NERVE BLOCK TRAY
K960100 · CAZ
Spinal Specialties, Inc.
Anesthesiology · 104d
Cleared Apr 24, 1996
PERCOR STAT-DL 9.5 FR. 34 & 40CC
K960166 · DSP
Datascope Corp.
Cardiovascular · 99d
Cleared Apr 24, 1996
ALADDIN MONITORING OXYGEN/AIR MIXER
K960359 · BZR
Hamilton Medical, Inc.
Anesthesiology · 90d