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
161281–161304 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 28, 1982
CORTISOL (RIA) KIT
K820074 · CGR
Immuno Assay Corp.
Chemistry · 16d
Cleared Jan 28, 1982
EMERSON THORACIC SUCTION REG. #55-JP
K820077 · KDP
J. H. Emerson Co.
General Hospital · 16d
Cleared Jan 28, 1982
POST-OP ELECTRODE (TENS ELECTRODE)
K820082 · GXY
Consolidated Medical Equipment, Inc.
Neurology · 16d
Cleared Jan 28, 1982
SUTTER CPM
K820083 · BXB
Sutter Biomedical, Inc.
Physical Medicine · 16d
Cleared Jan 28, 1982
CURITY SURGICAL SCRUB BRUSH SPONGE
K820086 · GEC
The Kendal Co.
General & Plastic Surgery · 16d
Cleared Jan 28, 1982
TSH (RIA) KIT
K820089 · JLW
Immuno Assay Corp.
Chemistry · 15d