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: General Hospital ×
17,766 results
14953–14976 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 50ML/CC
K864779 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 29, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 20ML/CC
K864781 · FMF
Mac Lee Medical Products
General Hospital · 21d
Cleared Dec 24, 1986
CARETEX SHOE COVERS
K864550 · FXP
James River Corp.
General Hospital · 35d
Cleared Dec 23, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 1ML/CC
K864780 · FMF
Mac Lee Medical Products
General Hospital · 15d
Cleared Dec 23, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE/SYRINGE 10ML/CC
K864782 · FMF
Mac Lee Medical Products
General Hospital · 15d
Cleared Dec 23, 1986
MACLEE/BOIN MEDICA STERILE NEEDLE & SYRINGE 5ML/CC
K864783 · FMF
Mac Lee Medical Products
General Hospital · 15d
Cleared Dec 18, 1986
BUTTERFLY NON-CORING NEEDLE SET
K863606 · FMI
Cormed, Inc., Sub. C.R.Bard, Inc.
General Hospital · 93d
Cleared Dec 18, 1986
MANAN CONTRAST MEDIA ADMINISTRATION SET
K864405 · FPA
Manan Manufacturing Co., Inc.
General Hospital · 38d
Cleared Dec 18, 1986
SEAL SYRINGE (3CC,5CC,12CC,20CC,30CC & 50CC)
K864414 · FMF
Seal Syringe Corp.
General Hospital · 41d
Cleared Dec 18, 1986
ANGEL LATEX SURGICAL GLOVES
K864521 · KGO
Kim Intl. Trading Co.
General Hospital · 31d
Cleared Dec 18, 1986
EXTENSION SETS
K864692 · FPK
Salt Creek Medical Technologies
General Hospital · 16d
Cleared Dec 18, 1986
CK 6000 SERIES, TOWELS
K864697 · KKX
Currie Medical Specialties, Inc.
General Hospital · 16d
Cleared Dec 17, 1986
ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP.
K863122 · FRC
Surgicot, Inc.
General Hospital · 125d
Cleared Dec 16, 1986
CRIS ADAPTED WITH VOLUME LIMITING BAG
K864164 · FPA
Y
General Hospital · 54d
Cleared Dec 16, 1986
STA-SET MODEL 250 I.V. FLOW REGULATOR
K864229 · LDR
Sta-Set Corp.
General Hospital · 49d
Cleared Dec 16, 1986
LOW VOLUME EXTENSION SET
K864395 · FPK
Panamedix, Inc.
General Hospital · 40d
Cleared Dec 16, 1986
USI AUTOJECT INSULIN SYRINGE
K864761 · FMF
Ulster Scientific, Inc.
General Hospital · 11d
Cleared Dec 12, 1986
ABBOTT LIFECARE(R) 4100 PCA INFUSER
K863997 · FRN
Abbott Laboratories
General Hospital · 59d
Cleared Dec 12, 1986
MODEL 504-S EXTERNAL INFUSION PUMP FOR DIABETICS
K864517 · FRN
Medtronic Minimed
General Hospital · 25d
Cleared Dec 11, 1986
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
K862153 · FOZ
Arrow Intl., Inc.
General Hospital · 189d
Cleared Dec 10, 1986
PHARMACOKINETICS SOFTWARE SYSTEM (PPS)
K864121 · NDC
Pharmatrol, Inc.
General Hospital · 50d
Cleared Dec 09, 1986
PRESELECTED FLOW RATE I.V. SET
K863304 · FPA
Migada, Ltd.
General Hospital · 106d
Cleared Dec 09, 1986
CARETEX ISOLUTION GOWNS
K864479 · FYC
James River Corp.
General Hospital · 26d
Cleared Dec 04, 1986
INTRACATH INTRAVENOUS CATHETER PLACEMENT UNIT
K861725 · FOZ
Parke-Davis Co.
General Hospital · 212d