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
167065–167088 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1980
PERFRINGENS SUPPLEMENT B
K800263 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
CHLORAMPHENICOL ANTIBIOTIC SUPPLEMENT
K800264 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
BORDETELLA SELECTIVE SUPPLEMENT
K800265 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
CAMPYLOBACTER GROWTH SUPPLEMENT
K800266 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
CAMPYLOBACTER SELECTIVE SUPPLEMENT
K800267 · JSK
Oxoid U.S.A., Inc.
Microbiology · 35d
Cleared Mar 12, 1980
MEDSPEC RAYON BALLS
K800277 · FRL
Medspec Corp.
General Hospital · 36d
Cleared Mar 12, 1980
MEDSPEC RUBBER ELASTIC BANDAGES
K800280 · FQM
Medspec Corp.
General Hospital · 36d
Cleared Mar 12, 1980
MEDSPEC PACKING GAUZE
K800281 · GDY
Medspec Corp.
General & Plastic Surgery · 36d
Cleared Mar 12, 1980
CRITERION II PACING SYSTEM MONITORS
K800286 · DTC
Dart Medical Equipment
Cardiovascular · 33d
Cleared Mar 12, 1980
CENTRIFICHEM FILTER CALIBRATION SET
K800304 · JIW
Union Carbide Corp.
Chemistry · 29d
Cleared Mar 12, 1980
DAVOL EMS ADAPTER, CAT. NO. 13-7664
K800317 · GEI
Electrocaine Medical System
General & Plastic Surgery · 29d
Cleared Mar 12, 1980
BUN REAGENT
K800341 · CDQ
Gilford Diagnostics
Chemistry · 26d
Cleared Mar 12, 1980
MODEL 795U BEHIND THE EAR HEARING AID
K800345 · ESD
Danavox, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 12, 1980
FLUID DISPENSING SYSTEM
K800362 · KYX
Pharmaseal Laboratories
General Hospital · 21d
Cleared Mar 12, 1980
ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202
K800364 · DKX
Hoffrel Instruments, Inc.
Toxicology · 21d
Cleared Mar 12, 1980
OPHTHALMIC FORCEPS
K800368 · HNR
Edward Weck, Inc.
Ophthalmic · 21d
Cleared Mar 12, 1980
CK/LD ISOENZYME CONTROL PROD. #ACS CT101
K800370 · JJY
Analytical Control Systems, Inc.
Chemistry · 21d
Cleared Mar 12, 1980
TENDERLIFT
K800373 · FMR
Competent Design
General Hospital · 21d
Cleared Mar 12, 1980
AMERLEX T-3 RIA KIT
K800374 · CDP
Amersham Corp.
Chemistry · 20d
Cleared Mar 12, 1980
NML 5000 AUTO. GAMMA SCINT. COUNTER
K800388 · JJJ
Nuclear Medical Laboratories, Inc.
Toxicology · 16d
Cleared Mar 12, 1980
PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT
K800398 · DEW
Diagnostica, Inc.
Immunology · 15d
Cleared Mar 12, 1980
MAXUM DENTURE RESIN
K800400 · EBI
Dentsply Intl.
Dental · 15d
Cleared Mar 12, 1980
INFRASONDE D4000 ELECTRONIC B-P MONITOR
K800401 · DXN
Sphygmetrics, Inc.
Cardiovascular · 15d
Cleared Mar 12, 1980
FERRIS BONE MARROW BIOPSY-ASPIR. NEEDLE
K800406 · GDM
A.D.T. Lab Industries
General & Plastic Surgery · 15d