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
134041–134064 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 07, 1988
GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS
K883394 · JWY
Baxter Healthcare Corp
Microbiology · 27d
Cleared Sep 07, 1988
TECHNICON DPA-1 APOLIPOPROTEIN B
K883491 · MSJ
Technicon Instruments Corp.
Immunology · 22d
Cleared Sep 07, 1988
TECHNICON DPA-1 IMMUNOGLOBULIN G
K883494 · DAH
Technicon Instruments Corp.
Immunology · 22d
Cleared Sep 07, 1988
QM300 RHEUMATOID FACTOR ANTIGEN PACK
K883536 · DHR
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Sep 07, 1988
QM300 CALIBRATOR E PACK
K883538 · DHR
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Sep 07, 1988
EX-CELL 300TM, CATALOG NO. 200-3600
K883623 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 300TM, CATALOG NO. 200-3601
K883624 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 301, CATALOG NO. 200-3651
K883625 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 301, CATALOG NO. 210-3577
K883626 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150
K883627 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051
K883628 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013
K883629 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
RPMI-1640 MEDIUM, CATALOG NO. 210-3525
K883630 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 300TM, CATALOG # 210-3579
K883631 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 07, 1988
EX-CELL 300TM, CATALOG NO. 210-3575
K883632 · KIT
J R Scientific
Pathology · 16d
Cleared Sep 06, 1988
ZEPHYR
K880534 · FXX
Racal Health & Safety, Inc.
General Hospital · 210d
Cleared Sep 06, 1988
SAM(TM) MODEL ONE
K880725 · BZQ
Sentel Tech. C/O Criticare Systems, Inc.
Anesthesiology · 196d
Cleared Sep 06, 1988
PATIENT VENTILATOR ISOLATOR
K880923 · CBK
Dryden Corp.
Anesthesiology · 186d
Cleared Sep 06, 1988
NUMED BALLOON THERMODILUTION CATHETER
K881893 · KRB
NuMED, Inc.
Cardiovascular · 124d
Cleared Sep 06, 1988
EOL, MODEL LIO
K881984 · HLI
Eol, Inc.
Ophthalmic · 117d
Cleared Sep 06, 1988
PHOTO-CURING LIGHT
K882145 · EBZ
Dentsply Intl.
Dental · 106d
Cleared Sep 06, 1988
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · LDF
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Sep 06, 1988
BOW & ARROW DRILL GUIDE
K882407 · LXI
Instrument Makar, Inc.
Orthopedic · 88d
Cleared Sep 06, 1988
DISPOSABLE ARACHNOID KNIFE
K882422 · HAO
Microbio-Medics, Inc.
Neurology · 85d