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
132073–132096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1989
AM TM SYRGICAL DRAPES
K882643 · KKX
Henley Intl.
General Hospital · 249d
Cleared Mar 03, 1989
CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200
K884025 · KNS
Circon Acmi
Gastroenterology & Urology · 162d
Cleared Mar 03, 1989
REMOTE VACUUM BOOSTER SYSTEM, 7600 SERIES
K884103 · GCX
Boehringer Laboratories
General Hospital · 155d
Cleared Mar 03, 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · FRO
Baxter Healthcare Corp
General & Plastic Surgery · 88d
Cleared Mar 03, 1989
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION
K885281 · KRA
Baxter Healthcare Corp
Cardiovascular · 66d
Cleared Mar 03, 1989
AGEN DIMERTEST EIA
K890189 · DAP
Agen Biomedical , Ltd.
Hematology · 45d
Cleared Mar 03, 1989
KOSAN ANGEL LATEX SURGICAL GLOVES (STERILE)
K890311 · KGO
Kosan Far East Ent. , Ltd.
General Hospital · 39d
Cleared Mar 03, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR TRF
K890563 · DDG
Atlantic Antibodies
Immunology · 38d
Cleared Mar 03, 1989
MALIS BIPOLAR CORD/IRRIGATION TUBING SET
K890648 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 23d
Cleared Mar 02, 1989
CAVROLAB
K882585 · IYN
Life-Tech Intl., Inc.
Radiology · 253d
Cleared Mar 02, 1989
KMI OXY-BAN
K883848 · KPJ
Knight Medical, Inc.
General & Plastic Surgery · 171d
Cleared Mar 02, 1989
ASTRO TRACE (MODEL AT-01)
K884592 · DSA
The LE Blanc Corp.
Cardiovascular · 119d
Cleared Mar 02, 1989
MODEL OX-1 OXYGEN SATURATION MODULE
K884822 · DQA
Colin Medical Instruments Corp.
Anesthesiology · 104d
Cleared Mar 02, 1989
LYME ELISA TEST SYSTEM
K885317 · LSR
Zeus Scientific, Inc.
Microbiology · 62d
Cleared Mar 02, 1989
SARNS VENT CATHETER
K890024 · DWF
3M Company
Cardiovascular · 57d
Cleared Mar 02, 1989
DENTOCULT SM-STRIP MUTANS
K890199 · JSI
Orion Corp.
Microbiology · 43d
Cleared Mar 02, 1989
KONTRON PULSE OXIMETER 7840
K890299 · DQA
Kontron Instruments, Inc.
Anesthesiology · 42d
Cleared Mar 02, 1989
SMDS460 SURGICAL MONITOR DISPLAY SYSTEM
K890353 · DXJ
Vidco, Inc.
Cardiovascular · 37d
Cleared Mar 02, 1989
PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.
K890492 · DXO
Endosonics Corp.
Cardiovascular · 30d
Cleared Mar 02, 1989
WELLSHIRE EMLINK MODEL 1000
K890508 · DXH
American Executive Technology
Cardiovascular · 29d
Cleared Mar 02, 1989
LANCER - MODULAR POWER BASE
K890723 · ITI
Everest & Jennings, Inc.
Physical Medicine · 17d
Cleared Mar 01, 1989
SENSATIONS BRAND CONDOMS
K871358 · HIS
Apex Medical Technologies, Inc.
Obstetrics & Gynecology · 695d
Cleared Mar 01, 1989
MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.
K882080 · HFM
Aequitron Medical, Inc.
Obstetrics & Gynecology · 288d
Cleared Mar 01, 1989
STANDARD LATEX CONDOM
K884399 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 133d