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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
89233–89256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 28, 1998
ETEST TETRACYCLINE
K981134 · JWY
Ab Biodisk
Microbiology · 59d
Cleared May 28, 1998
LICEMEISTER COMB
K981250 · LJL
National Pediculosis Assoc.
General Hospital · 52d
Cleared May 28, 1998
ICON FXHCG URINE/SERUM TEST, ICON FXHCG URINE TEST, MODELS 40025,40050, 40005...
K981512 · JHI
Skd, Inc. A Beckman Coulter Co.
Chemistry · 30d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT)
K981584 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 28, 1998
ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)
K981585 · LDJ
Roche Diagnostic Systems, Inc.
Toxicology · 24d
Cleared May 27, 1998
MANAN NEPHROSTOMY DRAINAGE CATHETER
K980192 · LJE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 127d
Cleared May 27, 1998
MANAN GENERAL UTILITY DRAINAGE CATHETER
K980193 · LJE
Medical Device Technologies, Inc.
Gastroenterology & Urology · 127d
Cleared May 27, 1998
ETEST CEFTRIAXONE
K980345 · JWY
Ab Biodisk
Microbiology · 118d
Cleared May 27, 1998
ETEST TETRACYCLINE
K980347 · JWY
Ab Biodisk
Microbiology · 119d
Cleared May 27, 1998
HOPE NEBULIZER
K980407 · CAF
B&B Medical Technologies, Inc.
Anesthesiology · 113d
Cleared May 27, 1998
OSTEONICS ANTEVERTED NECK HA HIP STEMS
K980766 · MEH
Osteonics Corp.
Orthopedic · 89d
Cleared May 27, 1998
ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV...
K980917 · GCA
Fortune Medical Instrument Corp.
Gastroenterology & Urology · 77d
Cleared May 27, 1998
3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
K980989 · KMF
Innovative Technologies , Ltd.
General & Plastic Surgery · 72d
Cleared May 27, 1998
SIMAL CERVICAL STABILIZATION SYSTEM
K981008 · KWQ
Top Surgical Products GmbH
Orthopedic · 70d
Cleared May 27, 1998
ALKPHASE-B ASSAY KIT
K981373 · CIN
Metra Biosystems, Inc.
Chemistry · 41d
Cleared May 27, 1998
ALBP
K981457 · CJW
Abbott Mfg., Inc.
Chemistry · 34d
Cleared May 27, 1998
ALBG
K981468 · CIX
Abbott Laboratories
Chemistry · 34d
Cleared May 27, 1998
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
K981607 · CIB
Diagnostic Systems Laboratories, Inc.
Chemistry · 22d
Cleared May 27, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K981626 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared May 26, 1998
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
K973360 · LDF
Medtronic Vascular
Cardiovascular · 260d
Cleared May 26, 1998
VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER
K973544 · CCK
Vacumed, Div. of Vacumetrics, Inc.
Anesthesiology · 250d
Cleared May 26, 1998
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
K973545 · CCL
Vacumed, Div. of Vacumetrics, Inc.
Anesthesiology · 250d
Cleared May 26, 1998
BRANEMARK SYSTEM DEC 600 DRILLING UNIT
K974123 · DZE
Nobel Biocare Uas, Inc.
Dental · 204d
Cleared May 26, 1998
AIRPREP SYSTEM - MODEL 9001
K974488 · KOJ
Asi Medical, Inc.
Dental · 181d