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
130609–130632 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1989
LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030
K891574 · JGT
Em Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Jun 09, 1989
IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES
K891583 · FRN
Y
General Hospital · 81d
Cleared Jun 09, 1989
LISTERIA SELECTIVE ENRICHMENT MEDIUM
K891593 · JSI
Oxoid U.S.A., Inc.
Microbiology · 81d
Cleared Jun 09, 1989
ZAROLAN, DUALAN, TITAN AND SUPERON
K891698 · EBF
Dent Zar, Inc.
Dental · 81d
Cleared Jun 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891880 · LYY
Jextrag Schaffhausen AG
General Hospital · 73d
Cleared Jun 09, 1989
BICARBONATE
K891991 · KHS
Boehringer Mannheim Corp.
Chemistry · 73d
Cleared Jun 09, 1989
INNOFLUOR(TM) QUINIDINE REAGENT SET
K892208 · LBZ
Innotron of Oregon, Inc.
Toxicology · 67d
Cleared Jun 09, 1989
INNOFLUOR(TM) QUINDINE CALIBATOR SET
K892212 · DLJ
Innotron of Oregon, Inc.
Toxicology · 67d
Cleared Jun 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892288 · LYY
Ansell, Inc.
General Hospital · 64d
Cleared Jun 09, 1989
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
K892424 · CFF
Helena Laboratories
Chemistry · 60d
Cleared Jun 09, 1989
SR1 (FSH) IMMUNOENZYMETRIC ASSAY
K892706 · CGJ
Serono-Baker Diagnostics, Inc.
Chemistry · 56d
Cleared Jun 09, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892741 · LYY
Dmacs Intl. Corp.
General Hospital · 59d
Cleared Jun 09, 1989
PATIENT EXAMINATION GLOVES
K893056 · LYY
Hope Rubber Industrial Corp.
General Hospital · 57d
Cleared Jun 09, 1989
PLYMOUTH & LAWANA EXAM GLOVES
K893149 · LYY
Healthgard Medical Products Ltd....
General Hospital · 26d
Cleared Jun 09, 1989
REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181
K893223 · JHO
Helena Laboratories
Chemistry · 43d
Cleared Jun 09, 1989
TRU TRAC TRACTION TABLE
K893448 · ITH
Tru-Trac
Physical Medicine · 37d
Cleared Jun 09, 1989
COMMUNI-CALL
K893473 · ILQ
Carepartners, Inc.
Physical Medicine · 36d
Cleared Jun 08, 1989
EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010
K883865 · CBK
Acutronic Medical Systems AG
Anesthesiology · 268d
Cleared Jun 08, 1989
STAR SYNC
K884521 · CBK
Infrasonics Corp.
Anesthesiology · 224d
Cleared Jun 08, 1989
RESPITRAK
K884959 · BZK
Non-Invasive Monitoring Systems, Inc.
Anesthesiology · 191d
Cleared Jun 08, 1989
EXTENSION SET W/FLOW REGULATOR
K890489 · FPA
Baxter Healthcare Corp
General Hospital · 128d
Cleared Jun 08, 1989
MEDSURG EPIDURAL TRAY 19 GAGE/ECON/BULLET TIP 1000
K890730 · CAZ
Medsurg Industries, Inc.
Anesthesiology · 115d
Cleared Jun 08, 1989
DATA EXCHANGE SYSTEM, MODEL 24
K890921 · CBK
Siemens Life Support Systems
Anesthesiology · 104d
Cleared Jun 08, 1989
PLAYTEX PORTABLES NON-DEODORANT & DOED. TAMPONS
K891297 · HIL
Playtex Family Products, Inc.
Obstetrics & Gynecology · 87d