Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
162121–162144 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 1982
DATAPASS
K812435 · IYO
General Electric Co.
Radiology · 156d
Cleared Jan 28, 1982
PIPERACILLIN 100 MCG. SENSITIVITY DISCS
K812524 · JTN
Difco Laboratories, Inc.
Immunology · 148d
Cleared Jan 28, 1982
PILLING LACRIMAL INTUBATION SYSTEM
K813187 · HNL
Narco Scientific
Ophthalmic · 73d
Cleared Jan 28, 1982
SERACULT OCCULT BLOOF TEST
K813204 · KHE
Propper Mfg. Co., Inc.
Hematology · 76d
Cleared Jan 28, 1982
INTERSEPT CARDIOTOMY RESERVOIR/FILTER
K813205 · DTB
Extracorporeal Medical Specialities,...
Cardiovascular · 76d
Cleared Jan 28, 1982
OXYGENAIRE NURING INCUBATOR
K813239 · FMZ
Vickers America Medical Corp.
General Hospital · 72d
Cleared Jan 28, 1982
CONPHAR DIGITAL THERMOMETER
K813306 · FLL
Conphar, Inc.
General Hospital · 66d
Cleared Jan 28, 1982
SKINNY CHIBA NEEDLE & TRAY
K813337 · FSH
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 65d
Cleared Jan 28, 1982
BIOPSY NEEDLES & TRAYS
K813338 · FSH
American Pharmaseal Div. Ahsc
General & Plastic Surgery · 65d
Cleared Jan 28, 1982
UVA FLUORESCENT TANNING LAMPS
K813451 · IOB
North American Philips Corp.
Radiology · 49d
Cleared Jan 28, 1982
FETASCAN 1000, 1000A OBSTETRICAL DATA
K813458 · HGM
Cranbury Medical Labs, Inc.
Obstetrics & Gynecology · 49d
Cleared Jan 28, 1982
COAG-A-MATE X2
K813564 · GKP
General Diagnostics
Hematology · 37d
Cleared Jan 28, 1982
MODEL AS6B INFUSION PUMP
K813590 · FRN
Baxter Healthcare Corp
General Hospital · 31d
Cleared Jan 28, 1982
MINIWASH II
K813640 · LIB
Dynatech Corp.
Chemistry · 28d
Cleared Jan 28, 1982
JMS DISPOSABLE SYRINGE
K813646 · FMF
Philadelphia Biologics Center
General Hospital · 28d
Cleared Jan 28, 1982
JMS NEEDLE & MAC JECT
K813648 · FMI
Philadelphia Biologics Center
General Hospital · 28d
Cleared Jan 28, 1982
PBC NEEDLE
K813649 · FMI
Philadelphia Biologics Center
General Hospital · 28d
Cleared Jan 28, 1982
GAS GENERATING KIT, CO2
K820010 · KZJ
Oxoid U.S.A., Inc.
Microbiology · 23d
Cleared Jan 28, 1982
SC-IT IMPEDANCE TESTER
K820040 · GYA
Cadwell Laboratories, Inc.
Neurology · 21d
Cleared Jan 28, 1982
TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY
K820043 · LIB
American Dade
Chemistry · 21d
Cleared Jan 28, 1982
CAMPYLOBACTER THIOGLYCOLLATE MED W/5
K820060 · JSJ
Bd Becton Dickinson Vacutainer...
Microbiology · 17d
Cleared Jan 28, 1982
SUSCEPTROL
K820064 · JTR
American Type Culture Collection
Microbiology · 17d
Cleared Jan 28, 1982
COLD-HOT PACK
K820068 · IME
Hospital Marketing Services Co., Inc.
Physical Medicine · 16d
Cleared Jan 28, 1982
MODEL 5790 GAS CHROMATOGRAPH
K820071 · KZQ
Hewlett-Packard Co.
Toxicology · 16d