FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
8617–8640 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Feb 09, 1999
PARAGON BOLUS ACCESSORY SET
K984638 · FPA
I-Flow Corp.
General Hospital · 40d
Cleared Feb 04, 1999
CLARICEL STERILIZATION POUCHES AND STERILIZATION REELS
K972719 · KCT
Medicel, S.A. DE C.V.
General Hospital · 563d
Cleared Feb 04, 1999
PERFUSOR COMPACT
K983005 · FRN
B.Braun Medical, Inc.
General Hospital · 160d
Cleared Feb 04, 1999
UNISEAL POWDER-FREE LATEX EXAMINATION GLOVES (BLUE & GREEN COLORED)
K983614 · LYY
American Healthcare Products (M) Sdn Bhd
General Hospital · 113d
Cleared Feb 04, 1999
SUBCUTANEOUS INFUSION SETS, MSR MODEL A & B
K984561 · FPA
Msr, Inc.
General Hospital · 43d
Cleared Feb 04, 1999
BROWNE SPORICIDIN PHENOL INDICATOR FOR SPORICIDIN STERILIZING AND...
K984613 · JOJ
Albert Browne , Ltd.
General Hospital · 37d
Cleared Feb 04, 1999
BROWNE SPORICIDIN GLUTARALDEHYDE INDICATOR FOR SPORICIDIN STERILIZING AND...
K984616 · JOJ
Albert Browne , Ltd.
General Hospital · 37d
Cleared Jan 29, 1999
CLINICATH POLYFLOW POLYURETHANE PERIPHERALLY INSERTED CATHETERS
K984055 · FOZ
Sims Deltec, Inc.
General Hospital · 77d
Cleared Jan 27, 1999
ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972616 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 562d
Cleared Jan 26, 1999
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972615 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 561d
Cleared Jan 26, 1999
VAGABOND SOFT RESTRAINT SYSTEM
K982178 · FMQ
Emergent Innovations, Ltd.
General Hospital · 218d
Cleared Jan 26, 1999
TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT...
K983145 · LYY
Shen Wei (Usa), Inc.
General Hospital · 140d
Cleared Jan 25, 1999
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
K984127 · LYY
Kilang Barangan Getah Dioh
General Hospital · 68d
Cleared Jan 25, 1999
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)
K984605 · LZA
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 28d
Cleared Jan 21, 1999
LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES
K982114 · LYY
M/S Midland Latex Products , Ltd.
General Hospital · 219d
Cleared Jan 21, 1999
NITRIKLEEN- NITRILE EXAMINATION GLOVE POWDER FREE
K983828 · LZA
Sinetimed Latex Sdn Bhd
General Hospital · 83d
Cleared Jan 21, 1999
POWDER FREE LATEX EXAMINATION GLOVES
K983998 · LYY
Sri Anusham Rubber Industries Pvt., Ltd.
General Hospital · 73d
Cleared Jan 20, 1999
STERIS TEN SIXTEEN STEAM STERILIZER
K982332 · FLE
STERIS Corporation
General Hospital · 202d
Cleared Jan 20, 1999
ROWE DUAL-CHECK VALVE
K983217 · FPA
Cook, Inc.
General Hospital · 128d
Cleared Jan 20, 1999
MPS GRAVITY FLOW CONTROL SET
K983926 · FPA
Critical Device Corp.
General Hospital · 76d
Cleared Jan 20, 1999
LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES
K984147 · LYY
Lovytex Sdn Bhd
General Hospital · 62d
Cleared Jan 14, 1999
ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN
K982058 · FYA
Encompass Group, LLC
General Hospital · 217d
Cleared Jan 14, 1999
INTROCAN SAFETY IV CATHETER
K982805 · FOZ
B.Braun Medical, Inc.
General Hospital · 157d
Cleared Jan 14, 1999
DENTAL STERLIZATION TRAY/CASSETTE
K983223 · FRG
Brasseler USA I, L.P.
General Hospital · 122d